Webinar Search

John E Lincoln

Risk-Based CAPA Systems
CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and key source of regulatory problems.
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$295.00

John E Lincoln

Changes and the 510(k)
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
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$295.00

Jeff Kasoff

Complaint Handling in Compliance with FDA and ISO Regulations
Negative customer feedback about a productâ€™s performance or safety is a strong indicator of whether a firm's manufacturing process is in control.
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$295.00

Jeff Kasoff

Supplier and Internal Auditing
The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company's personnel every day.
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$295.00

Jeff Kasoff

Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner
Supplier qualification and assessment is required in both the QSR regulations and ISO standards.
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$295.00

Anthony DeMarinis

Sterilization as a Benchmark for Cleaning Validation and Control
This webinar will review principles of sterilization validation and using them as a benchmark for more robust cleaning validation.
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$295.00

Anthony DeMarinis

Root Cause Analysis: Shutting Down the Alligator Farm
This webinar will use thoughtful discussion, humorous analogies and case studies to distinguish between the true root cause and other common imposters.
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$295.00

Markus Weber

Risk Management during device design according to ISO14971
The presentation provides practical tips to comply with ISO14971, implement risk management, and minimize the administrative burdens imposed to handle the additional process.
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$295.00

Markus Weber

Hazard Analysis - A practical guide
This presentation looks at what is required under IEC60601 and ISO14971, and provides guidance on how to motivate groups to perform hazard analysis, structure meetings effectively and make them meaningful.
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$295.00

Markus Weber

Residual Risk and Risk based Verification
Learn how to define the residual risk of your device and how to streamline the verification process by employing a risk based approach.
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$295.00

Roy E Costa

Farm to Fork Food Safety: Good Manufacturing Requirements for the Food Chain Post Slaughter and Harvest; Packers, Suppliers, Processors and Retail
Farm to Fork Food Safety: Good Manufacturing Requirements for the Food Chain Post Slaughter and Harvest; Packers, Suppliers, Processors and Retail
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$295.00

David R. Dills

Changes to the Medical Devices Directive 93/42/EEC
This webinar will provide valuable assistance and guidance to all regulated companies that are preparing for CE Mark and ensuring compliance to MDD 93/42/EEC.
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$295.00

David R. Dills

How to Manage a Medical Device Recall Efficiently and Effectively
This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.
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$295.00

David R. Dills

Conducting Successful Product Complaint Investigations
This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations.
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$295.00

John Chapman

Recalls & Vigilance-When to Report Complaints
This webinar will acquaint one with the lessons learned from over 30 years of adverse events and complaints.
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$295.00

Steven S Kuwahara

GMP for Phase 1 Products
This presentation will cover the contents of the guidance that was given.
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$295.00

Anthony DeMarinis

Calibration and Assuring Accurate Measurements
This discussion will provide individuals with a better understanding of data integrity and measurement variation sources.
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$295.00

Christopher P Young

Compliance Issue for Laboratories Related to Electronic Health Records (EHRs)
Health care reform efforts by the government will include significant pressure on the health care industry, including laboratories, to adopt electronic health records (EHRs) and the electronic transfer of information of all kinds between health care provi
Recorded View Anytime
$295.00

John E Lincoln

Best Selling Medical Device Webinars by John E. Lincoln
CompliancePanel brings you a special offer on Medical Device Recorded Webinars.
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$795.00

Steven S Kuwahara

GMP Perspectives on Working with Contracting Laboratories
This presentation will cover the responsibilities of both parties, and the procedures for assuring that responsibilities are met.
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$295.00

Steven S Kuwahara

Statistical Procedures Needed for Compliance with the New Draft Guidance on Process Validation
This guidance document contains several statements that make it clear that statistical procedures will be expected.
Recorded View Anytime Duration:75 Minutes
$295.00

John Chapman

ISO 13485 as a Quality Management System for Medical Devices
This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.
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$295.00

Edwin L Bills

How does Risk Management Impact Supply Management
This course will demonstrate how to use risk management tools effectively to select suppliers that impact safety and to communicate to suppliers where they need to apply special attention to reduce the risk of their products to the medical device manufact
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$295.00

Edwin L Bills

Use of Risk Management during Process and Design Validation
This presentation will discuss this critical interface between these three elements and give medical device manufacturers practical advice on implementation of a process that meets the requirements of all three areas.
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$295.00

Edwin L Bills

Proper Documentation of Risk Management for Compliance with ISO 14971
This presentation will deliver a practical discussion on the proper use of the tools available to conduct product risk management and achieve a result that complies and also provides a more complete product risk analysis resulting in reduced cost and impr
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$295.00

Charles H Pierce

What is the role of Data and Safety Monitoring in Clinical Research Involving Human Subjects - When and How?
All Clinical Research protocols have a prominent safety monitoring plan as part of the overall research plan / protocol.
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$295.00

Charles H Pierce

The Secret of Study Conduct Documentation to ensure a successful Audit: What the FDA Inspectors look for
All Clinical Research protocols have the procedures and processes needed to collect the data as it happens.
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$295.00

Charles H Pierce

How does compliance with 21 CFR Part 11 help ensure data integrity and subject safety in clinical research
Electronic medical records and electronic handling of study data is increasingly common.
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$295.00

Charles H Pierce

How the Investigator's responsibilities and Legal commitment's in drug and device clinical research affects Study Conduct . The FDA point of view
When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations.
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$295.00

John E Lincoln

Master Verification and Validation Planning to Meet US FDA, ISO 13485 and 14971 Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
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$295.00

Roy E Costa

Product Identification and Traceability
This webinar will provide valuable assistance to all companies that need to develop and implement Product Traceability Systems. including companies in the produce, meat, and processed food fields.
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$295.00

Roy E Costa

Foodborne Illness Outbreaks-Lessons Learned from the Mistakes of Others
This webinar will provide valuable assistance to all regulated companies that handle food during any stage of production and distribution.
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$245.00

Christopher P Young

No Place to Hide: The New Medicare Auditors and Their New Techniques
This session will describe the new environment and provide some tips and practical advise on steps labs should take to avoid becoming a target.
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$295.00

Bernice Russell Bond

Is your Laboratory Information Management System (LIMS) in compliance with 21 CFR Part 11 Subpart B - Electronic Records?
This webinar has been developed to provide clarification and interpretation on how to use LIMS in compliance with FDA Electronic Signatures and Electronic Records Rules.
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$295.00

Bernice Russell Bond

Are you on the correct path to ensure compliance of your Information Systems with 21 CFR Part 11?
This Webinar would benefit company personnel that are responsible for the procedural and/or software requirements to ensure compliance with Part 11 of Title 21 of the Code of Federal Regulation.
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$295.00

Bernice Russell Bond

Mitigate the risk that Excel Spreadsheets introduce to your company.s IT and operational environment under 21 CFR Part 11
End User Computing can be audited and control by manual process; using automated tools; or by the ideal method eliminating the need for end user computing by incorporating the computations to information systems controlled by the information technology de
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$295.00

Bernice Russell Bond

How Control Frameworks document compliance with Sarbanes Oxley (SOX), Section 404
Many have questioned whether the Sarbanes-Oxley law requirements can be met in a cost-efficient manner.
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$295.00

Mike Morley

Fast and Easy Sarbanes-Oxley Internal Controls for Accounts Receivable
This session will provide you with the tools you need to establish and maintain strong internal controls that reduce risk and protect company assets.
Recorded View Anytime
$245.00

Mike Morley

Sarbanes-Oxley: Demystifying the Documentation Process
This webinar will provide you with the tools to prepare SOX documentation that is easily understood and implemented.
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$215.00

Jeff Kasoff

Personnel Training to Assure QSR and ISO Compliance
This webinar will provide valuable assistance to all regulated companies, since personnel training is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.
Recorded View Anytime
$295.00

Jeff Kasoff

FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes
This webinar is designed for those who perform, supervise, manage, audit, or oversee the creation, approval, control of labels and labelling
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$295.00

Albert Cefalo

Risk Analysis: When does it start and When does it End
As a result of attending this presentation, the attendee will receive an overview of Risk Analysis which can be applied to all varieties of Medical Devices in the marketplace today.
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$295.00

Albert Cefalo

Design History Files: Their Content and Control
After attending this presentation the attendee should come away with a good knowledge of what the requirements for Design History Files are from both a domestic and international perspective, how to minimize DHF content so that the requirements are still
Recorded View Anytime
$295.00

Albert Cefalo

Report Requirements for Radiation Emitting Products; CeSub & ESG
By attending this webinar the attendee will become familiar with how the process works and what need to be done for access to the FDA ESG.
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$295.00

John E Lincoln

Avoid Warning Letters in View of the U.S. FDAâ€™s Stated Goal to Increase Their Use
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
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$295.00

John E Lincoln

The Design History File and the Technical File / Design Dossier
The DHF is a key element of Design Control under the GMPs, and is a major subject for review during a U.S FDA compliance audit.
Recorded View Anytime
$295.00

John Chapman

FMEA and Risk Management for Medical Devices
This presentation will explain the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.
Recorded View Anytime
$295.00

David R. Dills

Establish and Maintain an Effective Supplier Qualification Program
This webinar will provide a valuable and informative overview and guidance to manufacturers, especially medical device companies that are preparing to establish or have established supplier/vendor management qualification programs.
Recorded View Anytime
$295.00

John E Lincoln

Product Risk Management - ISO 14971:2007
This webinar will address the use of the ISO 14971 model to perform and document such activities and the additional actions necessary to make it a useful product reference and training tool.
Recorded View Anytime
$295.00

Jeff Kasoff

How to Prepare for, Manage, and Follow-up to an FDA Inspection
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Recorded View Anytime
$295.00

Bernice Russell Bond

Risk Management Frameworks - Why are they important and Why have them
This webinar has been developed to provide clarification and interpretation on how to use LIMS in compliance with FDA Electronic Signatures and Electronic Records Rules.
Recorded View Anytime
$295.00

Bernice Russell Bond

What Controls need to be in place to reduce the risk of compromising Electronic Personally Identifiable Information (PII)
Prior to the development of a new system or the modification of an existing application that will collect, process and/or store PII, business reasons supporting these practices must documented.
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$295.00

Edwin L Bills

Integrating Risk Management Into the Quality System
ISO 14971 medical device risk management standard was updated in 2007 after its initial release in 2000.
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$295.00

Edwin L Bills

The New FDA-Product Approval, Inspection, and Enforcement
The US Food and Drug Administration has recently released information about its new strategies as a result of the new administration.
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$295.00

Albert Cefalo

GMP Training for Manufacturing and Administration Personnel
If you read the FDA quality system regulation clause 820. 25 (personnel) it states that: "Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibi
Recorded View Anytime
$295.00

Albert Cefalo

MDD Essential Requirements: An Overview
Any medical device manufacturer seeking market clearance in the European Community must meet and follow the Medical Device Directive or MDD. Since its original release in1993 there have been several updates to this directive, the most significant of whic
Recorded View Anytime
$295.00

Jeff Kasoff

A CAPA Primer - Elements of a CAPA Program and Uses of CAPA Data
A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer.
Recorded View Anytime
$295.00

Jeff Kasoff

Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Relatively Paper-Free Manner
A document control system is required for compliance with federal (FDA) and international (ISO) compliance.
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$295.00

Jeff Kasoff

Management Controls Under QSR and ISO 13485
The top management of a company is responsible for ensuring that all regulatory requirements are met.
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$295.00

Jeff Kasoff

Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements
There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field.
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$295.00

John E Lincoln

Risk-based Software Verification and Validation
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Recorded View Anytime
$295.00

Christopher P Young

Practical information for conducting laboratory compliance audits: auditing the billing process
This session will provide a practical approach to conducting comprehensive billing audits of a clinical laboratory that include a start to finish audit process for a non-statistical probe audit.
Recorded View Anytime
$295.00

David R. Dills

FDA's Update on Medical Device Labeling Changes
FDA recently released a final rule regarding the parameters in which a device manufacturer can modify label changes to a product.
Recorded View Anytime
$295.00

David R. Dills

Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends
CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.
Recorded View Anytime
$295.00

David R. Dills

Managing Your Medical Device Reporting (MDR) Program for Compliance Success
Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly.
Recorded View Anytime
$295.00

Denise Mainquist

PCI Compliance: Who, How and Why? If you accept credit card payments, you must comply
Any entity that stores, processes or transmits credit card information must be in compliance with the Payment Card Industry Data Security Standard (PCI DSS).
Recorded View Anytime
$245.00

David Nettleton

Computer Systems Used in Clinical Trials
This interactive webinar provides an overview of techniques used for buying, deploying, validating, and maintaining computer systems used for clinical trials.
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$295.00

Denise Mainquist

PCI DSS: Why companies claim they are compliant when they're not
There is no "close enough" when it comes to compliance with the PCI DSS.
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$295.00

Steven S Kuwahara

Understanding Analytical Test Results: Comparing Two Sets of Data
The class will cover the understanding the properties of single test results and how they may be compared.
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$295.00

Albert Cefalo

Device Master Record & Device History Record: A Regulatory Overview
After completion of this webinar the attendee will have a thorough understanding of the what these two important parts of a GMP compliant quality management system are, and how they are established, implemented and controlled.
Recorded View Anytime
$295.00

Albert Cefalo

Design Changes: When is a New 510(k) Required
This webinar will provide an overview of the FDA guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device".
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$295.00

Albert Cefalo

Quality System Records: Origin and Controls
The establishment, implementation and maintenance of a Quality Management System (QMS) requires records to provide evidence of implementation to a third party or an internal audit organization.
Recorded View Anytime
$295.00

Albert Cefalo

Verification & Validation: Their Similarities and Differences
Before the design process is completed and your product or device is ready for the marketplace, verification and validation are imperative.
Recorded View Anytime
$295.00

Anthony DeMarinis

Incorporating Risk Management into Process Improvement
This webinar will benefit process owners and improvement teams assigned to develop FMEAs and improve process output and efficiency.
Recorded View Anytime
$295.00

John Chapman

Regulatory Complaint Handling, Vigilance & Recalls
Improper complaint handling can result is serious regulatory problems as well as hitting the bottom line.
Recorded View Anytime
$295.00

Steven Walfish

Avoiding Statistical Pitfalls during Method Validation
The ICH guideline on Validation of Analytical Procedures (Q2R1) delineates the guidance and methodology for validation characteristics of an analytical procedure.
Recorded View Anytime
$295.00

Steven Walfish

Introduction to Design of Experiments and ANOVA
This seminar will give the audience a high level overview of different statistical design of experiments and how to analyze the data.
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$295.00

Steven Walfish

Supplier Risk Management
One of the hottest topics facing the medical device industry is the evaluation and control of suppliers.
Recorded View Anytime
$295.00

David Nettleton

Excel Spreadsheets â€“ Step-By-Step Instructions for Compliance
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.
Recorded View Anytime
$295.00

David Nettleton

How to Conduct a Hazard Analysis/Risk Assessment
This interactive webinar teaches how to determine and document risk in a process in order to reduce validation time and ensure compliance.
Recorded View Anytime
$295.00

Teri C. Soli

Key Concepts in Successful Water System Sanitization
Though hardly a water system is designed and installed without some capability of sanitization, the system design features, materials of construction, sanitization chemical choices and how they are used, as well as the frequency of the sanitization proces
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$295.00

Teri C. Soli

Water System Biofilm Control and Microbial Monitoring Myths
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
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$295.00

John E Lincoln

Root Cause Analysis â€“ Starting at the Beginning
Root Cause Analysis (RCE) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Recorded View Anytime
$295.00

John E Lincoln

Meet the New, Tougher FDA Expectations
The last few years have seen the U.S. FDA come under increasing negative public scrutiny.
Recorded View Anytime
$295.00

Andrew Brooker

The importance of creating an information security policy
The first step in executing a proactive information security strategy is to create a solid, enforceable, Information Security Policy (ISP).
Recorded View Anytime
$245.00

Edwin L Bills

Process Validation for Medical Device Manufacturers
All medical device companies are required to review its manufacturing processes to determine which processes require process validation, and which processes may be qualified by other methods.
Recorded View Anytime
$295.00

Edwin L Bills

Control of Products and Services Obtained from Suppliers
The US FDA has discovered that a reasonably large number of recalls and adverse events are related to supplied product.
Recorded View Anytime
$295.00

Edwin L Bills

Risk Management in IEC 60601-1 Third Edition
IEC 60601-1 Third Edition was released in late 2005. It is a new philosophy in standards for medical electrical devices to accommodate rapid advances in technology.
Recorded View Anytime
$295.00

Edwin L Bills

Business, Project and Compliance Risk
Companies have been applying the techniques of ISO 14971 to product safety, but the techniques can also be applied to other risks encountered in all companies.
Recorded View Anytime Duration:90 Minutes
$295.00

John E Lincoln

Setting Up and Running a Tougher Supplier Audit Program
The last few years have seen the U.S. FDA come under increasing negative public scrutiny.
Recorded View Anytime
$295.00

Jasmin NUHIC

21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection
21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries.
Recorded View Anytime
$295.00

Jasmin NUHIC

21 CFR Part 11: Auditing for Part 11 Compliance
21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries.
Recorded View Anytime
$295.00

Melinda Allen

Webinar on Quality System Documentation Development
How to Develop World Class Quality Systems that will comply with the new audits such as BRC, SQF, Retail and Restaurant Brands.
Recorded View Anytime Duration:60 Minutes
$215.00

Jeff Kasoff

The 510(k) Submission: Requirements, Contents, and Options
This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly.
Recorded View Anytime Duration:60 Minutes
$295.00

Peter Calcott

FDA GMP inspections - preparation and conduct are the keys to success
Although unannounced GMP inspections happen when you least expect them, it is possible to predict when they occur.
Recorded View Anytime
$295.00

David Nettleton

Ten-Step Process for COTS Computer System Validation - Reduce Time and Costs
This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs.
Recorded View Anytime
$295.00

David Nettleton

Risk Assessment-Compliance Using Easy To Fill Out Documentation
This webinar teaches how to determine and document risk in a process in order to reduce validation time and ensure compliance.
Recorded View Anytime
$295.00

Richard Poser

Internal 21CFR Part 11 Compliance Auditing of Computer Systems
This presentation will describe a proven process for preparing a site for inspection of systems.
Recorded View Anytime
$295.00

Richard Poser

Risk-Based Validation of cGMP Systems
This presentation will review a methodology for implementing Risk-Based Validation of test equipment, facilities and analytical instruments used in GLP, cGMP and GCP facilities.
Recorded View Anytime
$295.00

Richard Poser

Analytical Instrument and Equipment Qualification in Quality Laboratories
The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing.
Recorded View Anytime
$295.00

Richard Poser

Software Vendor Qualification and Auditing
Inspection and auditing of vendors which provide software used to support GXP manufacturing and testing will be explained and illustrated through audit forms, processes and checklists.
Recorded View Anytime
$295.00

Richard Poser

Analytical Test Method Qualification and Validation
The scientific and regulatory requirements for analytical test method validation change as drug products and medical devices are developed from R&D through pre-clinical, clinical and commercial phases It is important to know when to do what - unnecessary
Recorded View Anytime
$295.00

Denise Mainquist

PCI Data Breaches: What happened? What may have prevented it? What if it happens to you?
If your organization is struggling to meet compliance requirements for PCI, you're in good company. Unfortunately, in this case there is no safety in numbers. Criminals do not necessarily attack big companies; they go after whatever is easy. The cost of r
Recorded View Anytime
$215.00

Bernice Russell Bond

Understanding good Closed Loop CAPA system
Increased regulatory pressures, the latest customer mandates and internal quality initiatives are requiring companies to take a proactive and automated approach to their corrective action process.
Recorded View Anytime
$295.00

Denise Mainquist

PCI Compliance: Tips to avoid fines and litigation
In this webinar you will learn about some of the possible consequences of failure to comply with the PCI DSS.
Recorded View Anytime
$215.00

David R. Dills

Update on Unique Device Identifier for Device Manufacturers
Recent reports identified several potential benefits to widespread use of UDI, such as reducing medical errors, facilitating recalls, improving medical device reporting, and identifying incompatibility with devices or potential allergic reactions.
Recorded View Anytime
$295.00

Dan OLeary

Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans
This course provides the attendees with the tools needed to understand and implement acceptance sampling.
Recorded View Anytime
$295.00

Dan OLeary

Risk Management for Medical Devices - ISO 14971
This course provides the attendees with an overview of ISO 14971:2007 and implementation tips for an effective system for managing risk.
Recorded View Anytime
$295.00

Dan OLeary

A Unified Approach to Complaints, Servicing, and FDA Reporting
This course provides the attendees with the information to implement an effective system for managing and reporting adverse events.
Recorded View Anytime
$295.00

Dan OLeary

Managing the Medical Device Supply Chain
In this seminar, you will learn both the requirements for managing suppliers and the reasons for these requirements.
Recorded View Anytime
$295.00

John E Lincoln

Drafting a Software V&V Documentation Package and Protocol
The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.
Recorded View Anytime
$295.00

Steven S Kuwahara

GMP Expectations for Products Used in Early Phase IND Studies
FDA issued a guidance document covering GMP requirements for Phase 1 products.
Recorded View Anytime
$295.00

Steven S Kuwahara

Auditing Analytical Laboratories for FDA Compliance
Auditing analytical laboratories can be complex because of the preparation that is often required.
Recorded View Anytime
$295.00

Michael Funk

GxP(GLP,GCP,GMP) Computer Validation, A Business Perspective - An Investigator's point of view
When a GxP computer system is implemented, a wide array of critical elements must be addressed in accordance with regulations for successful and compliant implementation in support of business needs.
Recorded View Anytime
$295.00

Jeff Kasoff

How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system.
Recorded View Anytime
$295.00

Jeff Kasoff

Development of a Supplier Quality Auditor Training Program
To have an effective supplier audit program, your company must have an effective audit team.
Recorded View Anytime
$295.00

Jeff Kasoff

Regulatory Requirements for Process Validation and their Protocols for Medical Devices
It is the goal of every manufacturing firm to maximize profit. This is often accomplished by process automation.
Recorded View Anytime
$295.00

Jeff Kasoff

Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained
The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical
Recorded View Anytime
$295.00

Teri C. Soli

Water System Investigation "How-To's" and Example Case Studies
Aside from being mentored by a "master", there is usually no problem-solving guidance available when it comes to solving water system contamination problems or product contaminations that appear to have been caused by the water system.
Recorded View Anytime
$295.00

Teri C. Soli

Common Sense Water System Validation
Water system validation is often considered a necessary evil intended to merely satisfy a regulatory expectation.
Recorded View Anytime Duration:90 Minutes
$295.00

Nancy Duarte-Lonnroth

Drug Master Files (DMF's) - Understanding And Meeting Your Regulatory And Processing Responsibilities
This course provides attendees with a basic understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics.
Recorded View Anytime
$295.00

Michael Funk

GxP (GLP, GCP, GMP) Computer Validation . Leveraging Best Practices and Six Sigma Tools to Create Robust User Requirements
Participants of this webinar will receive valuable insights and tools to be used in the successful creation of a robust Requirements document. Information presented will include topics to be addressed when creating a User Requirements. Additionally, tool
Recorded View Anytime Duration:90 Minutes
$295.00

Dr. Ludwig Huber

Transfer of Analytical Methods and Procedures: FDA Requirements and Strategies and Tools for Implementation
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Recorded View Anytime
$295.00

Dr. Ludwig Huber

Validation and Use of ExcelÂ® Spreadsheets in FDA Regulated Environments
ExcelÂ® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Recorded View Anytime
$295.00

Albert Cefalo

Preparing a Medical Product Regulatory Requirement Plan
Prior to the development of or the acceptance of a contract for development of a medical product, an important step is the development of a Regulatory Requirements Plan for the product.
Recorded View Anytime
$295.00

Albert Cefalo

Elements of a Medical Device Requirement Specification
In order to start the ball rolling for new medical device and after the Marketing folks have provided R&D with their input, the Requirement Specification combines these processes.
Recorded View Anytime
$295.00

Albert Cefalo

Developing a Complete Product Quality Plan
The bridge between Product Concept and Customer delivery of a product, whether it be a medical device, a component or a commercial product, is the Product Quality Plan.
Recorded View Anytime
$295.00

John E Lincoln

Device Changes and the 510(k)
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Recorded View Anytime
$295.00

John E Lincoln

Process Verification / Validation Under HACCP, the cGMPS and ISO
FDA Warning Letters and recent recalls in the media show major cGMP deficiencies in companies' validation activities.
Recorded View Anytime
$295.00

John E Lincoln

Product Risk Management Under ISO 14971:2007 and ICH Q9
The U.S. FDA has stated that the use of a medical device or pharmaceuticals entails some degree of risk.
Recorded View Anytime
$295.00

John E Lincoln

Master Verification and Validation Planning Under the cGMPS and ISO 13485
FDA Warning Letters and recent recalls in the media show major cGMP deficiencies in companies' validation activities.
Recorded View Anytime
$295.00

Dan OLeary

Implementing QSR and ISO 13485 requirements for CAPA and Corrections
The difference between corrective action and preventive action is often confusing. There are, however, formal definitions that show the difference between them.
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$295.00

Dan OLeary

Process Validation for Medical Devices
This webinar explains the fundamental requirements for process validation in both FDA QSR and ISO 13485. You will learn when a process should be validated, the basic components of a process validation (IQ, OQ, and PQ) and how to write protocols and report
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$295.00

Dan OLeary

Statistical Concepts of Process Validation
The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".
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$295.00

David R. Dills

Medical Device Postmarketing Vigilance Reporting: Update and Expectations for Manufacturers
Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5) came into force on January 1, 2008.
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$295.00

John Chapman

Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries
ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards.
Recorded View Anytime
$295.00

Steven S Kuwahara

Risk Analysis in Pharmaceutical Manufacturing: A Regulatory Overview
The issue of risk management or risk assessment is becoming an important tool for decision making in the pharmaceutical industry.
Recorded View Anytime
$295.00

Steven Walfish

Using Statistical Methods for Effective Outlier Detection
Statistical outlier detection has become a popular topic as a result of the US Food and Drug Administration's out of specification (OOS) guidance and increasing emphasis on the OOS procedures of pharmaceutical companies.
Recorded View Anytime
$295.00

Mark Roberts

Understanding the alphabet soup of medical device standards â€“ ISO, EN, BS EN, AAMI, etc
Device approval, especially outside the US is driven by conformance to ISO, IEC and other standards.
Recorded View Anytime
$295.00

Edwin L Bills

Understanding the new IEC 60601-1 Third Edition
Now that the FDA has become the last regulator to indicate they will recognize IEC 60601-1 Third Edition, it is important that device manufacturers understand this standard as they need to begin implementation in current and future design projects of elec
Recorded View Anytime
$295.00

Edwin L Bills

CAPA and Risk Management
Manufacturers continue to struggle with CAPA systems as evidenced by FDA Warning Letters which show a large percentage of citations are for inadequate CAPA Systems.
Recorded View Anytime
$295.00

Edwin L Bills

Interfacing Design Verification, Process Validation and Design Validation
There is confusion between the requirements for Design Verification, Process Validation and Design Validation.
Recorded View Anytime
$295.00

John E Lincoln

Change Control - The Achilles Heel of cGMP Compliance
The last few years have seen an increase in product recalls. For this and other reasons, the U.S. FDA come under increasing negative public scrutiny.
Recorded View Anytime
$295.00

John E Lincoln

Webinar on CAPA Challenges
CAPA, Corrective and Preventive Action, is a major element of cGMP compliance. Sadly, it is also a key source of regulatory problems.
Recorded View Anytime
$295.00

Dr. Ludwig Huber

IT Infrastructure and Network Qualification - Introduction and Strategies for Compliance and System Uptime
Federal laws and regulations mandate to put controls and measures on a company network to ensure security and data integrity. Examples are 21 CFR Part 11, Sarbanes-Oxley Act, and HIPAA.
Recorded View Anytime
$295.00

David R. Dills

Construct and Manage the Technical File and Design Dossier
This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape.
Recorded View Anytime
$295.00

David R. Dills

Combination Products: FDA's Proposed Rule for GMP Requirements and Introduction and Expectations for "Combo" Products
What is a combination product? What are some examples of combination products? How are combination products assigned for review?
Recorded View Anytime
$295.00

Dr. Ludwig Huber

Good Laboratory Practice Regulations - Introduction and Strategies for Implementation
Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, what procedures are required and how to implement GLP regulations.
Recorded View Anytime
$295.00

Max Lazar

FDA GMP requirements for APIs
FDA's API GMP requirements may or may not be obvious to all parties. GMP is an expectation defined under the U.S. Food Drug and Cosmetic Act. This United States Law establishes the authority of the FDA.
Recorded View Anytime
$295.00

Max Lazar

ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs
Active Pharmaceutical Ingredient Good Manufacturing Practices (API GMP) are established and defined by the ICH Q7 Guidance.
Recorded View Anytime
$295.00

Max Lazar

Auditing API Manufacturers and Suppliers
This program will focus on the basics needed to perform an API audit. Performing an audit is not simply an act of visiting a firm and checking off a list of questions.
Recorded View Anytime
$295.00

Anthony DeMarinis

Root Cause Analysis and Documentation Requirements for CAPA
RCA is a popular topic and many companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur.
Recorded View Anytime
$295.00

Dr. Ludwig Huber

Handling OOS Test Results and Failure Investigations
No or inadequate procedures for handling out of specification (OOS) situations, failure investigations and corrective and preventive actions (CAPA) are amongst the most frequently found deviations in FDA warning letters.
Recorded View Anytime
$295.00

Dr. Ludwig Huber

Validation of Analytical Methods and Procedures
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data.
Recorded View Anytime
$295.00

Peter Calcott

FDA Inspections of Clinical Data Systems
The field of GCP has rapidly evolved over the last 20 and particularly the last 5 years and the requirements are getting tougher.
Recorded View Anytime
$295.00

Jeff Kasoff

The FDA Inspection Process: From SOP to 483
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Recorded View Anytime
$295.00

Jeff Kasoff

Design Control for Medical Device Professionals
Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed.
Recorded View Anytime
$295.00

Jeff Kasoff

Best Practices in Supplier Management
Supplier qualification and assessment is required in both the QSR regulations and ISO standards.
Recorded View Anytime
$295.00

Jeff Kasoff

Best Practices in Complaint Management
Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control.
Recorded View Anytime
$295.00

Albert Cefalo

Maintaining A Complete Design History File
No matter what you are designing and no matter what your industry, if your organization is certified to an international standard such as ISO13485 or ISO9001 you are required to establish and maintain a Design History File for all of your products.
Recorded View Anytime
$295.00

Albert Cefalo

Design Changes and 510(k)
All of us in the medical device industry who are marketing devices under the 510(k) substantial equivalence regulations occasionally make changes or improvements to our devices.
Recorded View Anytime
$295.00

Jasmin NUHIC

Complying with 21CFR Part 11 - Understanding the Role of Predicate Rules
More and more organizations are striving to "go green" and develop "sustainable" organization's strategies, which almost always includes using more and more of the computer technologies.
Recorded View Anytime
$295.00

Peter C. Teuten

Defining, Architecting and Managing Risk Assessments
Risk Assessments are a vital tool in the Risk and Compliance management arsenal.
Recorded View Anytime
$295.00

Dan OLeary

Excel Spreadsheets and FDA Device Regulations
This seminar helps you understand the FDA device regulations related to Excel spreadsheets.
Recorded View Anytime
$345.00

Dan OLeary

Regulatory Requirements for Medical Device Calibration Programs
Calibration is an essential component of every Quality Management System (QMS).
Recorded View Anytime
$295.00

Nancy Duarte-Lonnroth

Verification vs. Validation in Regulated Industries
This webinar will teach how Design Verification and Validation, Process Validation, Risk Management and Purchasing Controls work together to produce safe medical devices.
Recorded View Anytime
$295.00

Janet Gough

Part 11 and the Documentation Maze
This Webinar explains how Title 21 Code of Federal Regulations Part 11 impacts virtually all companies developing, manufacturing, and distributing therapeutic products or services.
Recorded View Anytime
$295.00

John E Lincoln

The DHF, Technical File and Design Dossier - Similarities, Differences and The Future
This webinar will examine the existing and proposed requiements for the FDA's DHF and the MDD's TF/DD. Differing purposes / goals.
Recorded View Anytime
$295.00

John E Lincoln

Meeting Tougher U.S. FDA Expectations - Update
This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs.
Recorded View Anytime
$295.00

Denise Mainquist

Virtualization in the PCI environment
Virtualization is a great approach to helping businesses meet goals for cutting capitalization and operational costs, creating energy efficiency and improving business continuity.
Recorded View Anytime
$215.00

David R. Dills

Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements
Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval.
Recorded View Anytime
$295.00

Steve Jolley

Drug Safety and Pharmacovigilance
This course will deliver an overview of drug safety and pharmacovigilance, including regulatory requirements for adverse event reporting.
Recorded View Anytime
$295.00

Edwin L Bills

Proper Use of Risk Management Tools for ISO 14971 Medical Device Safety
In this presentation we will use examples of the use of the tools for medical device risk management to complete the risk management process for a sample medical device.
Recorded View Anytime
$295.00

Edwin L Bills

Use of Risk Management to Meet Requirements of IEC 60601-1
This presentation will examine the requirements of IEC 60601-1 for use of ISO 14971 risk management and interpret those requirements.
Recorded View Anytime
$295.00

Edwin L Bills

Post-Design Medical Device Risk Management
In this presentation we will explore the requirements for post-design risk management and determine how to apply the requirements.
Recorded View Anytime
$295.00

Edwin L Bills

Why Medical Device Companies Receive Warning Letters
The Commissioner of the US FDA has stated the agency will be more enforcement oriented and quicker to issue Warning Letters. This presentation will review current enforcement practices of the US FDA with actual Warning Letters recently issued to medical d
Recorded View Anytime
$295.00

Angeline Benjamin

Product Recalls - Planning and Conducting Food Recall
Creating an effective Product recall process that will protect both the consumer and company's/brand's reputation requires careful planning and active involvement of each involved department.
Recorded View Anytime
$215.00

Melinda Allen

HACCP Validation and Verification
HACCP validation and verification is an often neglected area of the HACCP program.
Recorded View Anytime
$245.00

Pauline McGregor

Validation of HPLC methods- Back to basics and interpreting current guidelines for your intended purpose
Pharmaceutical products are ultimately released to the consumer based on a certificate analysis generated by laboratory testing.
Recorded View Anytime
$295.00

Gerry O'Dell

Important Sterilization Information for Product Developers
Product developers have the responsibility of the development of medical devices or healthcare products that will be sterilized; however they may not have an adequate understanding of the sterilization processes and its impact to the functionality of the
Recorded View Anytime
$295.00

Steve Jolley

Webinar on Pharmacovigilance Audit
This webinar will describe how to conduct a thorough drug safety and pharmacovigilance audit, including compliance with applicable worldwide laws, regulations and guidance.
Recorded View Anytime
$295.00

Steve Jolley

Signal Detection and Data Mining in Pharmacovigilance
This webinar will cover the fundamentals of signal detection, and how these can be augmented by the use of data mining techniques.
Recorded View Anytime
$295.00

Nancy Duarte-Lonnroth

Failure Modes and Effects Analysis (FMEA) - An Effective Tool for Medical Device Risk Management
Most medical device manufacturers use FMEA as a part of their risk management system. Risk Management is required by ISO 13485 and risk analysis by the FDA's Quality System Regulations (QSR) and by of the EU medical device regulations.
Recorded View Anytime
$295.00

Pauline McGregor

Verification of Pharmacopeia Methods
Laboratories that work in a GMP environment are required to have documentation to show they are qualified to run specific, consistent and reliable analytical test methods.
Recorded View Anytime
$295.00

Pauline McGregor

Quality by Design (QbD) and Analytical Methods
As the industry is moving towards applying Quality by Design (QbD) to process development, the question must be asked: Is this also the way forward to revolutionise, improve and standardise our approach to method development and qualification?
Recorded View Anytime
$295.00

Kerry Paul Potter

Pharmaceutical Manufacturing Batch Record Review
The FDA and its European counterpart, EMA, require drug manufacturers to have written procedures in place to document production and process controls, better known as batch records.
Recorded View Anytime
$295.00

Kerry Paul Potter

Good Documentation Practices for GMP Operations
Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance.
Recorded View Anytime
$295.00

Anthony G. Tarantino

Conduct Your Own Risk Assessments Following ISO Standard 31000/31010
For the last decade, there has been an extensive and organized effort by organizations to assess their risks, especially in financial services.
Recorded View Anytime
$215.00

Carlos M. Aquino

How to Survive a DEA Audit
This training entitled "How to Survive a DEA Audit" will cover all the record-keeping and security requirements that a DEA registrant must comply with when handling controlled substances and regulated chemicals.
Recorded View Anytime
$295.00

David N. Muchemu

Designing a Change Control System that Meets and Exceeds Compliance Requirements
This webinar equips the attendee with information required to design, manage, and sustain a change control system that meets and exceeds FDA requirements.
Recorded View Anytime
$295.00

John E Lincoln

Key Modules of an Effective CAPA SOP
This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs, especially CAPA.
Recorded View Anytime
$295.00

John E Lincoln

Design History File, and Technical File / Design Dossier - A Regulatory Overview
This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD.
Recorded View Anytime
$295.00

Angeline Benjamin

Improving Sanitation Standard Operating Procedures in the Food Industry
Foodborne illness is often traced to improper cleaning and sanitizing of food equipment and the environment.
Recorded View Anytime
$215.00

Dan OLeary

Outsourced processes and ISO 9001:2008
In 2008, a new edition of ISO 9001 went into effect. The literature says the new version doesn't introduce any new requirements but only clarifications to the existing requirements.
Recorded View Anytime
$295.00

Dr. Ludwig Huber

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourself for the upcoming FDA Part 11 Inspections
On July 8, 2010, the FDA announced to soon conduct a series of inspections related to 21 CFR Part 11.
Recorded View Anytime
$295.00

Dr. Norman F. Estrin

The Cosmetic-Cosmeceutical Distinction: Walking the Line in Developing Label Claims
Drafting claims where you "walk the line" between cosmetic and drug claims is an art with little existing practical guidance.
Recorded View Anytime
$295.00

Kerry Paul Potter

FDA Inspections - Do's & Don'ts
The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control.
Recorded View Anytime
$295.00

Jeff Kasoff

Understanding Corrective and Preventive Action, and Elements of a CAPA System
A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer.
Recorded View Anytime
$295.00

Jeff Kasoff

FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes
Marketing wants to entice customers to buy your product instead of your competitor's! A common method is to make the labeling as eye-catching as possible.
Recorded View Anytime
$295.00

Jeff Kasoff

Developing an Effective Supplier and Internal Auditing System
The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your companyâ€™s personnel every day.
Recorded View Anytime
$295.00

Jeff Kasoff

Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner
Document control can be a time- and paper-consuming process.
Recorded View Anytime
$295.00

Bernice Russell Bond

The HITECH Acts Impact on HIPAA
The new requirements of the HITECH Act have a significant impact on the privacy and security of health information.
Recorded View Anytime
$215.00

Angeline Benjamin

Developing and Implementing an Effective Product Specification
A good specification not only defines the product and process being purchased by the customer, but also serves as an extension of the purchasing contract.
Recorded View Anytime
$215.00

Nancy Duarte-Lonnroth

Effective & Essential CAPA process to avoid FDA 483
How do you prevent becoming another FDA statistic? Poor corrective and preventive action (CA/PA) and investigations continue to be among top FDA Form 483 deficiencies issued to drug, biologic, and medical device manufacturers.
Recorded View Anytime
$295.00

Nancy Duarte-Lonnroth

Preparing for FDA Inspections in a Changing Regulatory Environment
Ready for Inspection by Hamburg's FDA? Under Commissioner Hamburg's new enforcement policy, FDA has issued more warning letters more quickly than it has in years.
Recorded View Anytime
$295.00

Barbara A. McLaughlin

Auditing Computer System Validation Materials
This presentation will provide auditors who are not knowledgeable about computer system validation with a basic understanding of the requirements and expectations for validation documentation.
Recorded View Anytime
$295.00

David R. Dills

Managing the IDE (Investigational Device Exemption) Submission for Compliance Success
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] su
Recorded View Anytime
$295.00

David R. Dills

Managing Product Medical Device Recall Efficiently and Effectively
Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death.
Recorded View Anytime
$295.00

John Geigert

Secrets of an Effective CMC Regulatory Strategy for Biopharmaceuticals Part 1 - Cell Banking
Cell banking assures that an adequate supply of equivalent well-characterized cells exist for production over the expected lifetime of the biopharmaceutical.
Recorded View Anytime
$295.00

Gerry O'Dell

Troubleshooting ethylene oxide (EO) processes
Not every parameter in the EO sterilization process in critical for the determination of the SAL. This presentation will outline the various parameters and what actions should be taken when they are not compliant to the process specification.
Recorded View Anytime
$295.00

Dr. Mike Long

Robust Process Validation for Medical Devices
One of the most common reasons noted by the FDA for recalls of medical device is improper validation.
Recorded View Anytime
$295.00

Carlos M. Aquino

Law Enforcement and Pain Management
Class participants will familiarize themselves with the federal laws and regulations enforced by DEA pertaining to Schedules II though V controlled substances that are dispensed, or prescribed by a physician as part of a pain treatment plan.
Recorded View Anytime
$295.00

Dr. Norman F. Estrin

Revamping the 510(k) Clearance Process-Understanding FDA's Proposals
The FDA has proposed an overhaul of the 510(k) clearance system In its release of reports from two working groups, the FDA's goals are to increase the predictability and transparency of the 510(k) process and enhance FDA scientific decision-making.
Recorded View Anytime
$295.00

Anthony G. Tarantino

Introduction to Risk Management
This three hour overview of financial risk management will provide the fundamentals to risk management that all managers need to comprehend.
Recorded View Anytime
$465.00

Javier Kuong

Using SLAs to Facilitate Enterprise and IT Governance, Risk Management and Compliance (GRC)
This one-of-kind webinar is intended to provide you with practical guidelines on applying SLA concepts to your organization's GRC program.
Recorded View Anytime
$215.00

Steve Jolley

European Drug Safety and Pharmacovigilance Compliance
This webinar will describe European PV requirements, including compliance with applicable laws, regulations and guidance.
Recorded View Anytime
$295.00

Carlos M. Aquino

How to Survive a DEA Audit or FIND=FINE
This training entitled "How to Survive a DEA Audi or FIND=FINE" will cover all the record-keeping and security requirements that a DEA registered pharmacy must comply with when handling controlled substances and regulated chemicals.
Recorded View Anytime
$295.00

Dr. Ludwig Huber

FDA's New Enforcement of 21 CFR Part 11
FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations.
Recorded View Anytime
$295.00

Dan OLeary

Medical Device Classification - US and the EU as per MDD, CMDR and GHTF
In 1976, the FDA received authority to regulate medical devices. The plan, written into law, establishes three risk classes for devices (I, II, and III). The three risk levels require different types of control. The webinar explains the two dimensional system the FDA employs, classifying each device by risk class and associated panel. This leads to specific regulations for each device type.
Recorded View Anytime
$295.00

John E Lincoln

Master Verification and Validation Planning to Meet US FDA, ISO 13485 and 14971:2009 Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
Recorded View Anytime
$295.00

David R. Dills

Combination Products: FDA's Proposed Rule for GMP Requirements and Introduction and Expectations for "Combo" Products
What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product
Recorded View Anytime
$295.00

David R. Dills

FDA's Update on Medical Device Labeling Changes
FDA recently released a final rule regarding the parameters in which a device manufacturer can modify label changes to a product.
Recorded View Anytime
$295.00

Jasmin NUHIC

21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection
21 CFR Part 11 is FDA regulation for electronic signatures and electronic records.
Recorded View Anytime
$295.00

Jeff Kasoff

Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner
Supplier qualification and assessment is required in both the QSR regulations and ISO standards.
Recorded View Anytime
$295.00

John Chapman

Regulatory Complaint Handling, MDR's & Recalls
Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling.
Recorded View Anytime
$295.00

John E Lincoln

Project Management for FDA-Regulated Companies
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and ot
Recorded View Anytime
$295.00

Max Lazar

ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs
Active Pharmaceutical Ingredient Good Manufacturing Practices (API GMP) are established and defined by the ICH Q7 Guidance.
Recorded View Anytime
$295.00

Melinda Allen

Food Traceability Program and Efficacy Verification
Product traceability requirements for meeting Food Safety and Quality standards as required by BRC fundamental clause 5.0, SQF item 4.5, 9 CFR will be covered.
Recorded View Anytime
$215.00

Melinda Allen

BRC Risk Analysis
Risk Assessment is a fundamental and intuitive activity that is not new to manufacturing professionals.
Recorded View Anytime
$215.00

Nancy Duarte-Lonnroth

Value-Adding Internal Auditing: Learn how to get your Internal Audit System to promote improvements
Auditing is a critical function of a medical product company. It provides management with information about how effectively a company controls the quality of their processes and products.
Recorded View Anytime
$295.00

Dan OLeary

Statistical Concepts of Process Validation
The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output".
Recorded View Anytime
$295.00

Nancy Duarte-Lonnroth

The Most Common Problems in FDA Software Validation & Verification
In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U.S:
Recorded View Anytime
$295.00

Steven S Kuwahara

GMP Expectations for Products Used in Early Phase IND Studies
FDA issued a guidance document covering GMP requirements for Phase 1 products.
Recorded View Anytime
$295.00

Steven S Kuwahara

Understanding Analytical Test Results: Comparing Two Sets of Data
The class will cover the understanding the properties of single test results and how they may be compared.
Recorded View Anytime
$295.00

Edwin L Bills

Interfacing Design Verification, Process Validation and Design Validation
There is confusion between the requirements for Design Verification, Process Validation and Design Validation.
Recorded View Anytime
$295.00

	Risk Management in IEC 60601-1 Third Edition IEC 60601-1 Third Edition was released in late 2005. It is a new philosophy in standards for medical electrical devices to accommodate rapid advances in technology. Recorded View Anytime $295.00

Anthony DeMarinis

Root Cause Analysis: Shutting Down the Alligator Farm
RCA is a popular topic and many companies realize its importance in correcting problems.
Recorded View Anytime
$295.00

	Full Day Virtual Seminar - Reduce Software Validation Costs and Pass the New 21 CFR Part 11 Inspections This interactive one-day seminar details how to reduce costs associated with implementing, using, and maintaining computer systems in regulated environments. Recorded View Anytime $795.00

Steven Walfish

Using Statistics to Determine Sample Size
This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data.
Recorded View Anytime
$295.00

John E Lincoln

Device Changes and the 510(k)
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Recorded View Anytime
$295.00

Jeff Kasoff

Complaint Handling in Compliance with FDA and ISO Regulations
This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications.
Recorded View Anytime
$295.00

Dr. Ludwig Huber

Computer System Validation: Step-by-Step
Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Get complementary SOPs and checklists for easy implementation. Understand the structure of validation plan, documentation of ongoing performance, structure of validation report.
Recorded View Anytime
$295.00

Dr. Ludwig Huber

Validation and Use of Excel Spreadsheets in FDA Regulated Environments
Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Recorded View Anytime
$295.00

David N. Muchemu

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar is designed to outline the characteristic of an effective work instruction, and Standard operating procedure.
Recorded View Anytime
$295.00

John E Lincoln

Process Verification and Validation
This webinar will provide valuable guidance to regulated companies in development, implementation, or refinement of their manufacturing process verification and validation programs.
Recorded View Anytime
$295.00

Jim Sheldon-Dean

HIPAA Compliance and Workforce Training for Medical Practices
Training is required in a number of areas of the HIPAA regulations and their policy implementations at medical offices.
Recorded View Anytime
$215.00

Howard Cooper

Designing and Implementing the Quality System for Combination Products
The FDA generally defines combination products as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.
Recorded View Anytime
$465.00

Nancy Duarte-Lonnroth

Verification vs. Validation in Regulated Industries
This webinar will teach how Design Verification and Validation, Process Validation, Risk Management and Purchasing Controls work together to produce safe medical devices.
Recorded View Anytime
$295.00

Amnon Eylath

The Drug Development Process - From Discovery to Commercialization
An overview of the drug development process, reviewing key deliverables for each stage of the development path with a special focus on managing the development process when using external resources such as Contract Manufactures, Contract Testing Labs and Contract Research Organizations.
Recorded View Anytime
$295.00

Dan OLeary

Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans
This course provides the attendees with the tools needed to understand and implement acceptance sampling.
Recorded View Anytime
$295.00

Kerry Paul Potter

Good Documentation Practices in a Regulated Environment
Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance.
Recorded View Anytime
$295.00

Nancy Duarte-Lonnroth

The Use and Mis-use of FMEA in Medical Device Risk Management
This webinar will inform personnel at medical device companies on how to properly use Failure Modes and Effects Analysis (FMEA) in performing Risk Management.
Recorded View Anytime
$295.00

Carlos M. Aquino

"Know Your Customer" - The DEA Due Diligence
This training will cover several recommendations to improve Due Diligence when distributing Schedules II through V controlled substances and regulated chemicals to your customers and what steps can be taken to prevent the illicit use or diversion of any product sold to a customer.
Recorded View Anytime
$295.00

Anthony G. Tarantino

Introduction to Operational Risk
This three hour overview of financial risk management will provide the fundamentals to risk management that all managers need to comprehend.
Recorded View Anytime
$465.00

Norma Skolnik

Meeting FDA requirements for OTC Drug Labeling
The webinar will help participants review and understand FDA requirements for OTC Drug labeling and compliance. OTC Monographs and their importance to OTC Drug marketing in the U.S. will also be covered.
Recorded View Anytime
$245.00

David R. Dills

Construct and Manage the Technical File and Design Dossier
This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background.
Recorded View Anytime
$295.00

John Chapman

ISO 13485 as a Quality Management System for Medical Devices
This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.
Recorded View Anytime
$295.00

Jeff Kasoff

The 510(k) Submission: Requirements, Contents, and Options
This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly.
Recorded View Anytime
$295.00

John E Lincoln

The FDA's Working Group Reports, I & II - New Directions
This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do internally.
Recorded View Anytime
$295.00

Richard Poser

Internal 21CFR Part 11 Compliance Auditing of Computer Systems
This presentation will describe a proven process for preparing a site for inspection of systems.
Recorded View Anytime
$295.00

Richard Poser

Analytical Instrument and Equipment Qualification in Quality Laboratories
The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing.
Recorded View Anytime
$295.00

Teri C. Soli

Key Concepts in Successful Water System Sanitization
Though hardly a water system is designed and installed without some capability of sanitization, the system design features, materials of construction, sanitization chemical choices and how they are used, as well as the frequency of the sanitization process have everything to do with its success.
Recorded View Anytime
$295.00

Teri C. Soli

Water System Biofilm Control and Microbial Monitoring Myths
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Recorded View Anytime
$295.00

Steven Walfish

Understanding Statistical Sampling Plans for Audits
The purpose of auditing is to identify failures in the system or gross negligence.
Recorded View Anytime
$295.00

Robert J. Russell

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Recorded View Anytime
$465.00

Jeff Kasoff

Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements
There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field.
Recorded View Anytime
$295.00

Jeff Kasoff

Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained
The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF).
Recorded View Anytime
$295.00

John G. Lanese

FDA 483 Observations in the Laboratory. What went wrong? How can they be avoided?
In order to proactively address areas of concern to the FDA and other regulators, All units within each pharmaceutical firm should review recent regulatory observations and proactively establish programs or systems to address the regulatory concerns.
Recorded View Anytime
$295.00

John G. Lanese

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations
Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations.
Recorded View Anytime
$295.00

David R. Dills

Webinar on Medical Device Tracking
The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so.
Recorded View Anytime
$295.00

David R. Dills

Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process
This 3 hour Webinar is a primer and overview to the premarket notification process, i.e., a 510(k).
Recorded View Anytime
$465.00

Dr. Ludwig Huber

Understanding and Preparing for FDA's New Part 11 Inspection Program
Within the next few weeks and months the FDA will conduct a series of Part 11 related inspections.
Recorded View Anytime
$295.00

Melinda Allen

Preventive and Corrective Maintenance: Protect your assets, Protect your consumers
A how to guide to meeting customer expectations of the maintenance function.
Recorded View Anytime
$215.00

Melinda Allen

Chemical Control for Food Manufacturers: Ingredient, Cleaning and Hazardous Materials
A comprehensive review of an ideal chemical control program will be presented.
Recorded View Anytime
$215.00

John E Lincoln

101 cGMP To-Do List for 2011
This webinar will examine the broad range of issues a company's senior management and QA/RA need to consider in their annual Management Review of their existing quality management system.
Recorded View Anytime
$295.00

Charles H Pierce

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?
This Webinar deals with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance.
Recorded View Anytime
$295.00

Edwin L Bills

Medical Device Reporting Regulations and Violations
This presentation will review the Medical Device Reporting regulations and common violations leading to Warning Letter filings by FDA.
Recorded View Anytime
$295.00

Edwin L Bills

Why is CAPA so often cited in medical device inspections
This presentation will explore FDA Corrective Action and Preventive Action findings in medical device manufacturer quality systems to determine FDA's concerns.
Recorded View Anytime
$295.00

Steve Jolley

Webinar on Pharmacovigilance Audit
This webinar will describe how to conduct a thorough drug safety and pharmacovigilance audit, including compliance with applicable worldwide laws, regulations and guidance. In addition, attendees will learn how to compare the company's pharmacovigilance operations to applicable best practices.
Recorded View Anytime
$295.00

Jim Sheldon-Dean

New Changes to HIPAA: The latest changes in the regulations and what they mean to you
New regulations modifying the HIPAA Privacy and Security Regulations have been proposed and/or finalized to meet the privacy and security mandates within the HITECH Act in the American Recovery and Reinvestment Act of 2009.
Recorded View Anytime
$215.00

Jim Sheldon-Dean

Complying with HIPAA Security Rules: What's in the rules and how you can most easily prepare for compliance
If you handle any electronic patient information, don't miss this teleconference on compliance with the HIPAA security regulation.
Recorded View Anytime
$215.00

Dr. Ludwig Huber

Electronic Raw Data in Regulated Environments - Definition, Recording and Archiving
All regulations have strict requirements for electronic raw data and other e-records.
Recorded View Anytime
$295.00

Jeffery P. Drummond

Legal Risks in Social Media for Healthcare Providers
Most sophisticated businesses use social media sites such as Facebook, MySpace, Twitter, and LinkedIn to promote their services, connect with their customers, and as a overall component of their business strategy.
Recorded View Anytime
$215.00

Kerry Paul Potter

Effective Training Practices for FDA Compliance
This presentation will answer some of the frequent questions of new trainers or training managers. These include: worker training requirements, the frequency of training, how to design an effective training program, who is responsible for training, training effectiveness and training documentation.
Recorded View Anytime
$295.00

John E Lincoln

Project Management in a cGMP Environment
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
Recorded View Anytime
$295.00

John E Lincoln

Validating Excel and Word Applications Documents
Both the U.S. FDA and the EU's MDD require companies to be proactive in reducing risk while increasing user benefits.
Recorded View Anytime
$295.00

John E Lincoln

Changes and The 510(k)
This webinar will examine the broad range of issues to be considered by a company when reviewing 1) a series of minor changes or 2) one major change to an existing product having an existing 510(k), for the need for a new 510(k).
Recorded View Anytime
$295.00

David N. Muchemu

Labeling Requirements for Dietary Supplements
This webinar points out current labeling issues including misbranding that are eating into profitability of dietary companies.
Recorded View Anytime
$295.00

Markus Weber

Hazard Analysis vs. FMECA – Differences and Commonalities
The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously.
Recorded View Anytime
$295.00

Carlos M. Aquino

Controlled Substances and the Pharmacist
The public media has been reporting the abuse of narcotic drugs prescribed for pain management with its focus on the legitimacy of prescriptions and the dispensing by a pharmacist. Both federal and state regulations have placed the responsibilities on the physician who wrote the prescription and the pharmacist who filled the prescription.
Recorded View Anytime
$295.00

Jayne Pilot

Food Safety Management Systems - ISO 22000:2005
This presentation will assist organizations within the food chain to understand the requirements to meet the international standard for Food Safety Management.
Recorded View Anytime
$345.00

John Chapman

Reprocessing REUSABLE Medical Devices-Cleaning & Labeling Requirements
Much attention has been paid to the regulatory requirements of reprocessing SINGLE use devices.
Recorded View Anytime
$295.00

Jasmin NUHIC

21 CFR Part 11: Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar
21 CFR Part 11 is FDA regulation for electronic signatures and electronic records.
Recorded View Anytime
$515.00

Jasmin NUHIC

Effective Corrective and Preventive Actions (CAPA): 10 Steps to Success - GlobalCompliancePanel Virtual Seminar
This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success.
Recorded View Anytime
$515.00

Merlin K. L. Bicking

Practical Laboratory Statistics
This presentation will attempt to remove the fear of statistics that most people share.
Recorded View Anytime
$295.00

Mike Morley

International Financial Reporting Standards: The Basics
Where business is concerned the world is becoming a smaller place.
Recorded View Anytime
$195.00

Robert J. Finamore

FDA 21 CFR Part 11 for techies
Although Part 11 has been around for over a decade, lack of visibility can sometimes render compliance with this regulation an afterthought.
Recorded View Anytime
$295.00

John R. Godshalk

Fundamentals of Process Validation
Process Validation is required by FDA and most regulatory bodies. PV demonstrates consistency of pharmaceutical processes.
Recorded View Anytime
$295.00

Charles V. Gyecsek

Cleanroom & HEPA Filter Testing & Certification: An Owners Guide
This seminar concentrates on identifying and discussing testing and certification requirements associated with cleanrooms.
Recorded View Anytime
$295.00

Dan OLeary

Excel Spreadsheets and FDA Device Regulations
This webinar helps you understand the FDA device regulations related to Excel spreadsheets.
Recorded View Anytime
$295.00

John E Lincoln

Tougher U.S. FDA cGMP Compliance Audits - When You're Not Ready
There is an on-going major shift in the emphasis of U.S. FDA cGMP compliance audits.
Recorded View Anytime
$295.00

John E Lincoln

Change Control -- Your Company's GMP Weak Point
There is a pervasive public perception that the FDA has been ineffective in protecting the public.
Recorded View Anytime
$295.00

John E Lincoln

Developing and Using the Product Risk Management File or Report
Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies.
Recorded View Anytime
$295.00

John E Lincoln

Meet FDA Expectations for a Tougher Supplier Audit Program
There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard to change that perception.
Recorded View Anytime
$295.00

Dr Laura Brown

Project Management for Clinical Trials
This web seminar has been designed to provide you with a clear understanding of project management skills to apply to running clinical trials.
Recorded View Anytime
$295.00

David R. Dills

Recalls of Medical Devices in the US - Current Trends
Medical devices are classified into three classes, Class I, II, and III, based on the level of control necessary to assure the safety and effectiveness of the device. Recalls of Class II devices represent 61% of all device recalls over a review period, followed by Class III devices at 28%.
Recorded View Anytime
$295.00

David R. Dills

FDA's Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List
Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually.
Recorded View Anytime
$295.00

Jeff Kasoff

Purchasing and Supplier Controls in the Medical Device Industry
Supplier qualification and assessment is required in both the QSR regulations and ISO standards.
Recorded View Anytime
$295.00

Jeff Kasoff

How to use QSIT to Your Advantage
Virtually all field inspections performed by FDA inspectors are done according to the QSIT.
Recorded View Anytime
$295.00

Jeff Kasoff

Process Validation Principles and Protocols for Medical Devices
The benefit of a consistent process is that the yield meets expected criteria. Firms that are able to implement such processes minimize their process rejections and therefore maximize profit.
Recorded View Anytime
$295.00

Jeff Kasoff

Design Control for Medical Devices
Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed.
Recorded View Anytime
$295.00

Merlin K. L. Bicking

Understanding the Calibration Curve
This presentation will provide an overview of the rules and assumptions behind the calibration of analytical instruments.
Recorded View Anytime
$295.00

David Nettleton

Excel Spreadsheets – Step-By-Step Instructions for Compliance
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.
Recorded View Anytime
$295.00

Dr. Michael J. Miller

Validating Rapid Microbiological Methods
Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose.
Recorded View Anytime
$295.00

Jeff Boatman

FDA's 2011 Guidance on Process Validation - General Principles and Practices
Nearly two years after releasing a draft validation guidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official standard.
Recorded View Anytime
$295.00

Dan OLeary

Statistical Concepts of Process Validation
The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output".
Recorded View Anytime
$295.00

Edwin L Bills

Developing the Risk Management Plan
This presentation will review the requirements for the Risk Management Plan and discuss practical methods for meeting the requirements.
Recorded View Anytime
$295.00

Edwin L Bills

Documentation for IEC 60601-1 3rd Edition Compliance
In this presentation we will review the certification requirements for documentation of the clauses of IEC 60601-1 Third Edition.
Recorded View Anytime
$295.00

Edwin L Bills

Overall Residual Risk for Medical Devices
This presentation discusses practical methods of performing Overall Residual Risk Evaluation and methods for documenting the results of the evaluation activity. Overall Residual Risk Evaluation requires a cross-functional team to perform the evaluation, which will be an important part of this presentation.
Recorded View Anytime
$295.00

John Chapman

Regulatory Complaint Handling, Vigilance & Recalls
Improper complaint handling can result is serious regulatory problems as well as hitting the bottom line. Recalls, FDA Warning letters & even seizures could result.
Recorded View Anytime
$295.00

David N. Muchemu

Bringing Compliance To Design Control For Older Products
The webinar examines critical parts of design control after product release including: design change control, design validation, and the Design History File.
Recorded View Anytime
$295.00

David N. Muchemu

Off-Label Promotion of Medical Devices: Maximizing Your Performance Claims within FDA's Framework of Acceptable Practices
The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion.
Recorded View Anytime
$295.00

Jim Sheldon-Dean

HIPAA Breach Notification: What to do to prevent breaches, and what to do when they happen to you
The new HIPAA Breach Notification Rule required by the HITECH Act within the American Recovery and Reinvestment Act of 2009 went into effect September 23, 2009, requiring all HIPAA covered entities and business associates to follow a number of steps to be in compliance.
Recorded View Anytime
$215.00

Jim Sheldon-Dean

HIPAA Business Associates: How the regulations have changed, and what you need to do for compliance now
HIPAA Business Associate rules have changed in fundamental ways, with new responsibilities and obligations for HIPAA BAs.
Recorded View Anytime
$215.00

Dr. Ludwig Huber

Validation of Existing/Legacy Computer Systems for FDA/EU Compliance
When existing or legacy computer systems are used in FDA or equivalent international environments they should be validated, a process sometimes called retrospective validation.
Recorded View Anytime
$295.00

Carlos M. Aquino

Controlled Substances and the Hospital Pharmacy
This webinar will cover several recommendations to improve the hospital's Due Diligence when dispensing Schedules II through V controlled substances in a hospital setting and what steps that can be taken to detect and prevent the illicit use or diversion of any controlled substance.
Recorded View Anytime
$295.00

Kerry Paul Potter

Elements of the Lot Disposition Process
This program will provide the content for pharmaceutical manufacturing sites to establish sound quality management system procedures for the disposition of intermediates, API, drug substances, medical devices, finished product, and in-house manufactured components.
Recorded View Anytime
$295.00

Howard Cooper

Pharmaceutical and Medical Device Good Manufacturing Practices - Similarities and Differences
As a quality professional, you desire to have the very best quality system that operates effectively, efficiently and conforms to the appropriate quality standards to meet customer and user needs.
Recorded View Anytime
$295.00

Steven Walfish

Using Statistics to Determine Sample Size
This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data.
Recorded View Anytime
$295.00

John G. Lanese

Key Elements of ICH-Q10 Pharmaceutical Quality System
This webinar will discuss the evolution of the standards, describe a Pharmaceutical Quality System and discuss the transition to the Pharmaceutical Quality System.
Recorded View Anytime
$295.00

Kerry Paul Potter

Good Documentation Practices for GMP Operations
Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory employees must follow good documentation practices.
Recorded View Anytime
$295.00

John Chapman

Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries
ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards.
Recorded View Anytime
$295.00

Nancy Duarte-Lonnroth

The Use and Mis-use of FMEA in Medical Device Risk Management
The purpose of FMEA is to affect the design and the most practical time to do this is when competing designs are being considered, not after choices have been made, contracts signed, and prototypes being built and tested.
Recorded View Anytime
$295.00

Dr. Ludwig Huber

Calibration and Qualification in Analytical Laboratories
Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use.
Recorded View Anytime
$295.00

Dr. Ludwig Huber

FDA's New Enforcement of 21 CFR Part 11
FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations.
Recorded View Anytime
$295.00

Charles V. Gyecsek

Facilities Cleaning in Cleanrooms and Controlled Environments
This live webinar concentrates on proper cleanroom cleaning, and discusses tools, equipment, agents, personnel training, extent, and frequencies.
Recorded View Anytime
$295.00

Charles V. Gyecsek

Gowning Systems Used in Cleanrooms & Controlled Environments
This live webinar concentrates on identifying cleanroom garment systems, how they should be used, management of their supply, and control of human variables.
Recorded View Anytime
$295.00

Kerry Paul Potter

Requirements of the Master Production Record
This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records.
Recorded View Anytime
$295.00

Dan OLeary

Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans
This course provides the attendees with the tools needed to understand and implement acceptance sampling.
Recorded View Anytime
$295.00

Jeffery P. Drummond

Data Security Analysis for Healthcare Providers
Data Security Analysis for Healthcare Providers: The "meaningful use" rules relating to the adoption of Electronic Medical Records require regular assessment of data security risks. HIPAA re-contains similar requirements.
Recorded View Anytime
$215.00

Nancy Duarte-Lonnroth

Creating Successful Device History Record and keep FDA happy in the process
Many companies are confident that their record keeping for the firm's device history records is compliant to the Quality System regulation, yet when the FDA comes calling, FDA 483 DHR cites are written and warning letters, seizures or worse ensue.
Recorded View Anytime
$295.00

Nancy Duarte-Lonnroth

The Most Common Problems in FDA Software Validation & Verification
This webinar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers.
Recorded View Anytime
$295.00

David R. Dills

Conducting Successful Product Complaint Investigations
This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations.
Recorded View Anytime
$295.00

Jeff Kasoff

Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained
This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation.
Recorded View Anytime
$295.00

Jeff Kasoff

Complaint Handling in Compliance with FDA and ISO Regulations
This webinar will provide valuable assistance to all regulated companies, since complaint handling is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.
Recorded View Anytime
$295.00

David N. Muchemu

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar is designed to outline the characteristic of an effective work instruction, and Standard operating procedure.
Recorded View Anytime
$295.00

Richard Poser

Internal 21CFR Part 11 Compliance Auditing of Computer Systems
This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems.
Recorded View Anytime
$295.00

John Chapman

FMEA and Risk Management for Medical Devices
This presentation will explain the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.
Recorded View Anytime
$295.00

John Chapman

Recalls & Vigilance - When to Report Complaints
This webinar will acquaint one with the lessons learned from over 30 years of adverse events and complaints.
Recorded View Anytime
$295.00

John E Lincoln

Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.
Recorded View Anytime
$295.00

John E Lincoln

Root Cause Analysis - The Heart of a Successful CAPA Program
Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Recorded View Anytime
$295.00

John E Lincoln

Develop and Execute the Company Software V&V Program
The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.
Recorded View Anytime
$295.00

Max Lazar

Auditing an Active Pharmaceutical Ingredient (API) Contract Manufacturing Organization (CMO)
Auditing an API CMO or any API supplier is a specialty that requires knowledge and experience that is gained through exposure to the unique attributes associated with API manufacturing.
Recorded View Anytime
$295.00

Howard Cooper

Pharmaceutical and Medical Device Validation Guidance's - Similarities and Differences
This webinar will provide an overview of process validation for devices and pharmaceuticals.
Recorded View Anytime
$295.00

Charles H Pierce

The GCP-ICH Obligations of Sponsors, Monitors, and Investigators - barriers and solution
The principal objective in a new drug development program is to assess the benefit / risk ratio.
Recorded View Anytime
$295.00

Jim Sheldon-Dean

Information Security Risk Analysis: Meeting HIPAA Requirements and the Meaningful Use Objective
This session will present the background of the regulations that call for information security risk analysis and show how it fits in to an overall information security management process. The risk analysis process will be presented within the context of the overall risk prioritization and risk mitigation process, using an example.
Recorded View Anytime
$215.00

Jim Sheldon-Dean

HIPAA Security Policies and Procedures: Making them useful and relevant as well as compliant
If you handle any electronic patient information, don’t miss this teleconference on compliance with the extensive requirements for policies and procedures in the HIPAA security regulation.
Recorded View Anytime
$215.00

Jim Sheldon-Dean

HIPAA Enforcement and Compliance Audits: What the auditors want and how to be ready before they call
In this session we will discuss the HIPAA audit and enforcement processes and how they apply to covered entities and business associates.
Recorded View Anytime
$215.00

Steven S Kuwahara

GMP Expectations for Products Used in Early Phase IND Studies
FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.
Recorded View Anytime
$295.00

John G. Lanese

Most Effective Test Method Validation using USP 1225 & ICH Q2 to Avoid warning letters
Although the concept of test method validation is based on good science, the expectation that test methods in the pharmaceutical industry be validated was established by the USP in the 1980s and expanded as an international expectation for the industry with the publication of ICH Q2 in the mid 1990s.
Recorded View Anytime
$295.00

John E Lincoln

DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions
This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR.
Recorded View Anytime
$295.00

Richard Poser

Risk-Based Validation for GxP Facilities
This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan.
Recorded View Anytime
$295.00

Richard Poser

Analytical Test Methods Validation for GxP Laboratory Compliance: FDA, ICH and USP Requirements
This Validation training will address the regulatory requirements which apply at the various stages of development, and suggest proven strategies for compliant and phase-appropriate analytical method validation.
Recorded View Anytime
$295.00

Richard Poser

Vendor Qualification Auditing for FDA Computer System Compliance
This Vendor Qualification training will include sample forms and checklists which may be used by the participants, along with some initial training on the appropriate use of forms and checklists.
Recorded View Anytime
$295.00

Richard Poser

Auditing Systems for 21CFR Part 11 Compliance
Life sciences companies should regularly audit and assess computer systems for 21CFR Part 11 compliance, both their internal systems used in support of regulated GxP activities as well as systems used by their contract vendors for manufacturing, laboratory testing, drug safety and clinical studies. This is done routinely as self-assessment and inventory of existing systems, during the implementation of new systems, as during vendor qualification and periodic audits.
Recorded View Anytime
$295.00

Bernice Russell Bond

Good Closed Loop CAPA system – A Complete Understanding
This webinar will present how organizations can pursue continual improvements and address the concerns of non-conformances and develop corrective/preventive actions to prevent the repetition of these occurrences in the future.
Recorded View Anytime
$295.00

Melinda Allen

Webinar on Specification Development
A good specification not only defines the product and process being purchased by the customer, but also serves as an extension of the purchasing contract.
Recorded View Anytime
$215.00

Carlos M. Aquino

How to Survive a DEA Audit
This training entitled "How to Survive a DEA Audit" will cover all the record-keeping and security requirements that a DEA registrant must comply with when handling controlled substances and regulated chemicals.
Recorded View Anytime
$295.00

Angeline Benjamin

Product Recalls - Planning and Conducting Food Recall
Creating an effective Product recall process that will protect both the consumer and company's/brand's reputation requires careful planning and active involvement of each involved department.
Recorded View Anytime
$215.00

Nancy Duarte-Lonnroth

Key Factors in Auditing and Qualifying Suppliers and Vendors
This webinar will demonstrate how to implement an effective audit program. Regulatory agencies hold firms responsible for delivering high quality products that meet all established requirements and specifications.
Recorded View Anytime
$295.00

Nancy Duarte-Lonnroth

What to Expect and How to Prepare for FDA Inspections
As recent headlines demonstrate, non-compliance with US Food & Drug Administration US FDA laws and regulations could cost your firm millions.
Recorded View Anytime
$295.00

Nancy Duarte-Lonnroth

Developing an Effective CAPA Strategy through Root Cause Analysis of Failures & Deviations
Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause regulatory inspections. This webinar highlights FDA and EU regulations and how to successfully approach a failure investigation and engage in subsequent root cause analysis.
Recorded View Anytime
$295.00

Charles V. Gyecsek

Water System Design, Start-Up, and Validation
This webinar provides a thorough examination of water systems. We will explore the typical components used in water systems and how these components are combined to achieve intended water quality specifications.
Recorded View Anytime
$295.00

Charles V. Gyecsek

Introduction to Master Validation Plans
This webinar provides an introduction to the creation, implementation, and maintenance of Validation Master Plans.
Recorded View Anytime
$295.00

Charles V. Gyecsek

Human Behavior in Cleanrooms and Controlled Environments
This live webinar concentrates on identifying good and bad cleanroom behavior. It provides training in cleanroom contaminants and how they are affected by humans.
Recorded View Anytime
$295.00

Anthony G. Tarantino

Introduction to Risk Management
This three hour overview of financial risk management will provide the fundamentals to risk management that all managers need to comprehend. Regardless of job titles, risk management is a shared responsibility by all managers.
Recorded View Anytime
$465.00

John E Lincoln

Device Changes and the 510(k)
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Recorded View Anytime
$295.00

Kerry Paul Potter

Good Documentation Practices for Laboratory Operations
Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance.
Recorded View Anytime
$295.00

Dr. Ludwig Huber

Understanding and Implementing USP 1058: Analytical Instrument Qualification
Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.
Recorded View Anytime
$295.00

Norma Skolnik

Dietary Supplements and OTC Drugs - Adverse Event Reporting
Since passage of the Dietary Supplement & Nonprescription Drug Consumer Protection Act in Dec. 2007, FDA requires reporting of serious adverse events for dietary supplements and OTC drugs.
Recorded View Anytime
$295.00

Kerry Paul Potter

Master Production Record Requirements
This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records.
Recorded View Anytime
$295.00

Jeff Kasoff

The 510(k) Submission: Requirements, Contents, and Options
This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly.
Recorded View Anytime
$295.00

Jose Mora

Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) – Principles on Lean Documents and Lean Configuration
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry.
Recorded View Anytime
$295.00

Jose Mora

Controlled Document System for a Life Sciences manufacturing plant - principles of Lean Documents and Lean Configuration
Controlled documents are one of the foundational building blocks of a Quality Management System (QMS) for regulated industries.
Recorded View Anytime
$295.00

Jose Mora

Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration
Design Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls.
Recorded View Anytime
$295.00

John E Lincoln

CAPA Challenges and FDA Expectations
CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Recorded View Anytime
$295.00

Howard Cooper

The Controls for Outsourcing Manufacturing and Testing
"The Controls for Outsourcing Manufacturing and Testing" explores the use of outsourcing and how it impacts quality and compliance and the organization as a whole. The primary stakeholders and outsourcing include Quality, Research, Production, Laboratories, Purchasing/Procurement, Finance, and Senior Management.
Recorded View Anytime
$295.00

Jim Sheldon-Dean

HIPAA and Electronic Health Records: Meeting the new requirements and new regulations
he new and proposed HIPAA Privacy and Security regulations will be reviewed and their effects on the use of EHRs will be discussed. The proposed rules call for an ability to make an electronic copy of an individual's protected health information for any information held in an entity's designated record set.
Recorded View Anytime
$215.00

Anthony DeMarinis

Root Cause Analysis and Documentation Requirements for CAPA
RCA is a popular topic and many companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur.
Recorded View Anytime
$295.00

John Chapman

ISO 13485 as a Quality Management System for Medical Devices
This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.
Recorded View Anytime
$295.00

John R. Godshalk

Lyophilization: What you Need to Know, Validation and Regulatory Approaches
This course explores the science and art of lyophilization and discusses how the lyophilization cycle and process is developed and validated, along with the regulatory requirements for lyophilization.
Recorded View Anytime
$295.00

John R. Godshalk

Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects
This course explores some of the best practices of pharmaceutical facility design with an emphasis on the regulatory aspect.
Recorded View Anytime
$295.00

Jeff Kasoff

ISO 13485 for Medical Device QMS
This webinar will provide valuable assistance to all device manufacturers who wish to have a better understanding of the requirements of ISO 13485.
Recorded View Anytime
$295.00

Jeff Kasoff

How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.
Recorded View Anytime
$295.00

Jeff Kasoff

Design History File (DHF) Device Master Record (DMR) Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained
This webinar will provide valuable assistance to all device manufacturers, those who market solely within the US, or those who wish to market in the EU as well.
Recorded View Anytime
$295.00

Anthony DeMarinis

Webinar on Supplier Management
This talk includes the rationales behind the elements and policies of a good Supplier Management Program.
Recorded View Anytime
$295.00

David R. Dills

Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements
Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices.
Recorded View Anytime
$295.00

David R. Dills

Combination Products: FDA's Proposed Rule for GMP Requirements and Introduction and Expectations for "Combo" Products
This webinar will provide valuable assistance and guidance to device companies in involved in commercialization of combination products.
Recorded View Anytime
$295.00

David R. Dills

Construct and Manage the Technical File and Design Dossier
This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape.
Recorded View Anytime
$295.00

Dan OLeary

Device Master Record & Device History Record
The FDA's Quality System Regulation (QSR) requires each device manufacturer to compile the specifications and procedures for a medical device.
Recorded View Anytime
$295.00

Dan OLeary

Statistical Concepts of Process Validation
The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".
Recorded View Anytime
$295.00

John R. Godshalk

Good Deviation Practice: what you need to know
This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations.
Recorded View Anytime
$295.00

Jim Sheldon-Dean

HIPAA and Security Breaches: Most frequent issues and causes, and trends for future threats
The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not prepared to respond to a breach of PHI and report and document it properly. We will discuss the origins of the rule and how it works, including interactions with other HIPAA rules and penalties for violations.
Recorded View Anytime
$215.00

Mark Roberts

Validating Radiation Sterilization for Medical Device Industries
Gamma and E-Beam radiation has used for sterilization of medical devices for over 50 years. Both methods are validated following the same principles and standards. This webinar will provide an overview of the requirements to validate medical devices for both Gamma and E-Beam sterilization.
Recorded View Anytime
$295.00

Mark Roberts

Design, Planning and Conducting Effective Audits
Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and also be a source of improvement.
Recorded View Anytime Duration:60 Minutes
$295.00

Jim Sheldon-Dean

HIPAA Accounting of Disclosures: Expanded scope in proposed rule means new obligations
The session will walk the listener down the path from the current HIPAA Accounting of Disclosures rule, through the HITECH Act's required changes, and the into the proposed rule to implement HITECH which goes beyond what was required in the law and establishes a new right to an Access Report of all electronic PHI.
Recorded View Anytime
$215.00

Kerry Paul Potter

FDA Inspections - Do's & Don'ts
The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control.
Recorded View Anytime
$295.00

Merlin K. L. Bicking

Practical Laboratory Statistics
This presentation will attempt to remove the fear of statistics that most people share.
Recorded View Anytime
$295.00

John Chapman

Verification vs. Validation in Regulated Industries
Attend this webinar to understand the differences and benefits of verification and validation.
Recorded View Anytime
$295.00

Markus Weber

Residual Risk and Risk based Verification
Learn how define the residual risk of your device and how to streamline the verification process by employing a risk based approach.
Recorded View Anytime
$295.00

Markus Weber

Effective Hazard Analysis to meet FDA and ISO13485:2003 Risk Management Requirements
FDA-GMPs, known as Quality System Regulations (QSRs), and ISO 13485 require Risk Management as integral part of the development life cycle.
Recorded View Anytime
$295.00

Elise P. Miner

Master Validation Planning
A Validation Master Plan (VMP) is a critical part of a successful validation project. It documents the intended path to be taken for the validation of an entire organization, one or multiple plants, a single system or assembly line, or even a collection of similar equipment, to be qualified and eventually validated.
Recorded View Anytime
$295.00

John E Lincoln

Implementing or Validating cGMPs to 21 CFR 11, Electronic Records, Signatures - A Simpler Approach
The verification and validation of electronic records and electronic signature software is coming under increased scrutiny by the U.S. FDA.
Recorded View Anytime
$295.00

John E Lincoln

Avoiding Major Industry cGMP Failures – Recent Updates
U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820). They are then required to translate those regulations into procedures and work instructions.
Recorded View Anytime
$295.00

John E Lincoln

FDA's New Draft Guidance on Medical Device Changes and the 510(k)
This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. It will examine the broad range of issues to be considered by a company when reviewing 1) A series of minor changes or 2) one major change to an existing product having an existing 510(k), for the need for a new 510(k).
Recorded View Anytime
$295.00

John E Lincoln

Practical Project Management to Meet FDA Requirements
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
Recorded View Anytime
$295.00

Howard Cooper

Establishing a Reduced Testing Program for Pharmaceutical & Medical Device Components
Reduced testing test permits a medical product manufacturer to reduce testing of incoming components provided there are adequate controls on specification control, material qualification, supplier qualification & monitoring, material validation, and collaborative testing.
Recorded View Anytime
$295.00

Howard Cooper

Designing, Drafting, Writing, and Implementing The Quality Manual
This webinar will begin with a brief discussion about quality then begin to explore how quality manuals have evolved into a communications device that assists all functions to reach their goals and objectives.
Recorded View Anytime
$295.00

Carlos M. Aquino

How to Survive a DEA Inspection Series: Controlled Substances and Hospitals
This training will cover several recommendations to improve the hospital's Due Diligence when administering and dispensing narcotic drugs in a hospital setting and what steps to take to detect and prevent the illicit use or diversion.
Recorded View Anytime
$295.00

Jasmin NUHIC

21 CFR PART 11: Complete Manual for Compliance Success
FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection.
Recorded View Anytime
$295.00

Jasmin NUHIC

Understanding the Basic and Statistical Process Control
Statistical Applications includes topics related to basic statistical applications and advanced statistical applications such as statistical process controls (SPC).
Recorded View Anytime
$295.00

Amnon Eylath

Implementing a Quality Systems-Based Approach to GCP Compliance
Ensuring GCP quality has often been approached from the perspective of reviewing as many documents as possible, looking for errors and following up on corrections or making "notes to file." In order to design, implement, and maintain GCP compliance in an effective manner, a Quality Systems Approach should be adopted.
Recorded View Anytime
$295.00

Amnon Eylath

The Drug Development Process - From R&D to Commercialization
In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work in isolation, but must collaborate extensively to design, develop, manufacture, test, validate and commercialize new drugs. Successful commercialization depends on effective processes to bring both the drug supply manufacturing processes and controls as well as the associated data and knowledge to the levels required for an approvable launch.
Recorded View Anytime
$295.00

Edwin L Bills

The 510(k) Process and Risk Management
This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products.
Recorded View Anytime
$295.00

Edwin L Bills

The Use and Mis-use of FMEA in Medical Device Risk Management
This webinar will update personnel at medical device companies on the ISO 14971 standard and point them to the additional information available in the document under the informative annexes.
Recorded View Anytime
$295.00

Charles V. Gyecsek

Contamination Control Master Plans - Key Elements
This webinar concentrates on the value of creating a master plan for contamination risks within a GMP manufacturing company. It provides an introduction to the creation, implementation, and maintenance of a Contamination Control Master Plan.
Recorded View Anytime
$295.00

Max Lazar

Outsourcing or Purchasing API or Excipients – Key Steps
This Webinar is designed to focus the participants on issues that are broader than the classical GMP Audit practices that need to be addressed during any relationship that is being established between various parties - the contractor giver and the contact acceptor or the purchaser and the supplier.
Recorded View Anytime
$295.00

John E Lincoln

Meeting Annual U.S. FDA cGMP Training Requirements
There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.
Recorded View Anytime
$295.00

John E Lincoln

Meeting FDA Requirements for Software Verification and Validation Planning
The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.
Recorded View Anytime
$295.00

John E Lincoln

Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File- Design Dossier - Regulatory Requirements
This webinar will examine the existing and proposed requirements for the FDA's DHF -- including its derivative documents, the DMR and DHR.
Recorded View Anytime
$295.00

John E Lincoln

CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.
Recorded View Anytime
$295.00

Dr. Ludwig Huber

Understanding the New USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Recorded View Anytime
$295.00

Gbolahan Fatuga

Drug Development Process - From Discovery to Marketing
This webinar will provide a clinical and regulatory perspectives on requirements to take a new drug from research to market.
Recorded View Anytime
$295.00

Gbolahan Fatuga

Clinical Study Closeout Program
Database lock & study closure procedures often brings to mind anxiety and high stress moments for many clinical research professional. With this webinar, we will arm the audience with knowledge, tools, and strategies to alleviate such emotions.
Recorded View Anytime
$295.00

Charles H Pierce

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant
This Webinar deals with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance.
Recorded View Anytime
$295.00

Jeff Kasoff

The FDA Inspection Process: From SOP to 483
This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.
Recorded View Anytime
$295.00

Jeff Kasoff

Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner
This webinar will provide valuable assistance to all regulated companies that are interested in incurring less cost on supplier evaluation and assessment.
Recorded View Anytime
$295.00

Jeff Kasoff

Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner
This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.
Recorded View Anytime
$295.00

Jeff Kasoff

Equipment Validation, Tracking, Calibration, and Preventive Maintenance
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment.
Recorded View Anytime
$295.00

David R. Dills

FDA's 2011 Draft Guidance on Financial Disclosure by Clinical Investigators
This webinar will provide an overview and guidance to firms that are either going through or preparing to go through clinical trials and working with clinical investigators.
Recorded View Anytime
$295.00

David R. Dills

Draft Guidance for Device Industry and FDA - Postmarket Surveillance
This webinar will provide an overview and guidance to firms that are either going through or preparing to go postmarket surveillance activities.
Recorded View Anytime
$295.00

Howard Cooper

Effective Internal Auditing-Making Quality Systems More Efficient for the Medical Products Industry
The different types of internal audits and how they are approached will be discussed. The Internal Audit Lifecycle will be followed from beginning to end. It will be shown that. Internal audits are not simple exercises to determine compliance to some regulatory standards. Instead, the focus must be on auditing the company's quality system to determine if they are meeting their objectives and are effective in resolving quality issues.
Recorded View Anytime
$295.00

Markus Weber

Hazard Analysis – A practical guide
If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time.
Recorded View Anytime
$295.00

Markus Weber

Hazard Analysis vs. FMECA – Differences and Commonalities
The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously.
Recorded View Anytime
$295.00

Dan OLeary

Excel Spreadsheets and FDA Device Regulations
This seminar helps you understand the FDA device regulations related to Excel spreadsheets. These spreadsheets can be automated processes and create electronic records. Both of these aspects are regulated by the FDA, so device manufacturers must understand the regulations and how to apply them. The seminar begins with Excel methods to help ensure the spreadsheet produces the results you want.
Recorded View Anytime
$295.00

Nanda K. Subbarao

Does your Equipment Program Meet Current Regulatory Expectations
This Interactive webinar will begin with an overview of the GMP/GLP requirements for an Equipment system.
Recorded View Anytime
$295.00

Steven S Kuwahara

Working with the Pharmacopeias and Compendia
Every developed country has a pharmacopeia, including the European Union.
Recorded View Anytime
$295.00

John Chapman

Regulatory Complaint Handling, Vigilance & Recalls
Improper complaint handling can result is serious regulatory problems as well as hitting the bottom line.
Recorded View Anytime
$295.00

Jeff Kasoff

Best Practices in Complaint Management
Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.
Recorded View Anytime
$295.00

Jeff Kasoff

Purchasing and Supplier Controls in the Medical Device Industry
This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices.
Recorded View Anytime
$295.00

Jeff Kasoff

FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes
This webinar is designed for those who perform, supervise, manage, audit, or oversee the creation, approval, control of labels and labeling.
Recorded View Anytime
$295.00

Jeff Kasoff

How to Prepare for, Manage, and Follow-up to an FDA Inspection
<ul> <li>Does the FDA call in advance or just show up at my door? </li> <li>Where do I let the inspector go? </li> <li>Do I give them a tour? </li> <li>What should I let them see? </li> <li>Who should I let them talk to? Are they ever going to leave?</li> </ul>
Recorded View Anytime
$295.00

Rudy Pina

Clean Room Microbial Load and Characterization of Microorganisms in the Clean Room Environment
A summary of test methods will be covered, and a review of types of microorganisms that can be present, will be discussed.
Recorded View Anytime
$295.00

Jose Mora

Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration
Design Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls.
Recorded View Anytime
$295.00

Jose Mora

Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) – Principles on Lean Documents and Lean Configuration
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry.
Recorded View Anytime
$295.00

Howard Cooper

Pharmaceutical and Medical Device Good Manufacturing Practices - Similarities and Differences
This webinar will explore differences and similarities between these GMPs as well as show how they relate to other quality systems, regional regulations, and guidance documents. Examples include ICH, GHTF, ISO particularly ISO 13485 as well as European quality requirements. The considerable use of graphical techniques will enhance this learning experience. Questions are strongly encouraged.
Recorded View Anytime
$295.00

David R. Dills

Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process
This 3 hour Webinar is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA.
Recorded View Anytime
$295.00

David R. Dills

Conducting Successful Product Complaint Investigations
This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations
Recorded View Anytime
$295.00

Gerry O'Dell

Sterilization Process for Product Developers - A Complete Guide
Product developers have the responsibility of the development of medical devices or healthcare products that will be sterilized; however they may not have an adequate understanding of the sterilization processes and its impact to the functionality of the product and its package.
Recorded View Anytime
$295.00

John R. Godshalk

Responding to FDA 483's
Many companies know that a written response is required when the company is issued a 483 by FDA, but they do not know or understand the importance of timing and the response wording.
Recorded View Anytime
$295.00

John R. Godshalk

Good Documentation Practice for GxP Environments
This webinar will cover Good Documentation Practice for GxP environments. This webinar will explore what companies need to know to comply with regulations regarding documentation, what Good Documentation Practice is, what needs to be documented, why it is documented, and FDA expectations for documentation.
Recorded View Anytime
$295.00

Robert J. Russell

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Recorded View Anytime
$295.00

John Chapman

Reprocessing REUSABLE Medical Devices-Cleaning & Labeling Requirements
Much attention has been paid to the regulatory requirements of reprocessing SINGLE use devices.
Recorded View Anytime
$295.00

John G. Lanese

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations
Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future.
Recorded View Anytime
$295.00

John G. Lanese

FDA 483 Observations in the Laboratory. What went wrong? How can they be avoided?
In order to proactively address areas of concern to the FDA and other regulators, All units within each pharmaceutical firm should review recent regulatory observations and proactively establish programs or systems to address the regulatory concerns.
Recorded View Anytime
$295.00

Edwin L Bills

Risk Management in IEC 60601-1 Third Edition
IEC 60601-1 Third Edition was released in late 2005. It is a new philosophy in standards for medical electrical devices to accommodate rapid advances in technology.
Recorded View Anytime
$295.00

Miguel Montalvo

The new Process Validation Life-Cycle Approach and the need to apply statistical tools to demonstrate Process Capability as per the new PV definition
This webinar will describe the new Process Validation Life-Cycle Approach as defined in the revised FDA guideline. The three stages will be described in detail including: Process Design, Process Qualification and the Continued Process Verification.
Recorded View Anytime
$295.00

Robert J. Russell

The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectation
This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out effective clinical studies in the U.S. and EU.
Recorded View Anytime
$295.00

James E. Russell

Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA
This 90 minute live, interactive webinar will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations. We will also cover what qualifies a material as a dietary ingredient, considerations for manufacturers and distributors, requirements for compliant labeling and acceptable marketing claims. An update on FDA’s draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labeling Act (both introduced in 2011) will also be discussed. At the conclusion of this 75 minute presentation, there will be a 15 minute Q&A session with the speaker.
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$295.00

Robert J. Russell

Anticipated Changes to the EU Medical Device Directives; 2010 Changes and What the Future Holds for Licensees
This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
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$295.00

Miguel Montalvo

Change Control Management – From Design to Commercialization
There is a need to implement an adequate formal level of change control during engineering projects (referred to as an Engineering Change Control) after the approval of the equipment/systems specifications in addition to the more formal change control after the qualification of these systems.
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$295.00

John E Lincoln

U.S. FDA's Strategic Priorities for 2012 and Beyond
This webinar will examine the FDA's recently instituted annual "Strategic Priorities" initiative, with emphasis on 2012.
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$295.00

John E Lincoln

Device Changes and the 510(k) - FDA's Revised [Draft] Guidance
This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. It will examine the broad range of issues to be considered by a company when reviewing 1) A series of minor changes or 2) One major change to an existing product having an existing 510(k), for the need for a new 510(k).
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$295.00

John E Lincoln

Product Risk Management Under ISO 14971 and FDA-ICH Q9
Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies.
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$295.00

John E Lincoln

Implement a Tougher Supplier Audit Program
There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit.
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$295.00

John E Lincoln

Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File- Design Dossier - Similarities, Differences and The Future
This webinar will examine the existing and proposed requirements for the FDA's DHF -- including its derivative documents, the DMR and DHR.
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$295.00

John E Lincoln

Master Verification & Validation Planning under U.S. FDA cGMP, ICH Q-series and ISO 13485-14971 Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
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$295.00

Chinmoy Roy

Key Steps for Risk Assessment
The webinar focuses on effective implementation of QRM through the understanding of the ICH Q9 process and principles of QRM. By reviewing the standard terminology of risk management and laying the foundation for a more practical approach to applying the QRM principles of ICH Q9 to any biopharmaceutical manufacturing process and equipment, it enables you to speak the same "language of risk" as those of the regulators and thereby significantly reduces your companies exposure to audit failures.
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$295.00

Hedley Rees

Supply Chain Integrity and Security
The topic of supply chain integrity and security is relatively new in Pharma, having gained prominence in recent years for the reasons described above. Breach of security related to criminal activity is where the issues are most visible and enforcement activity is actively taking place around the globe. In parallel, if we are looking for sustainable, root cause solutions, we must also turn our attention to supply chain integrity and deal with both security and integrity concurrently.
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$295.00

Dr. Ludwig Huber

Verification of Compendial Methods according to the New USP Chapter 1226
This webinar will give a good understanding of USP and FDA requirement and provide recommendations and tools for effective implementation.
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$295.00

Dr. Ludwig Huber

Computer System Validation: Step-by-Step
This webinar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation.
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$295.00

Jeff Schwegman

Lyophilization Process Development and Cycle Design with a Case Study
This webinar will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle.
Recorded View Anytime
$295.00

Angela Bazigos

Excel Spreadsheet Validation for FDA 21 CFR Part 11
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
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$295.00

Angela Bazigos

FDA's 21 CFR 11 Add-On Inspections - Recent Updates
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
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$295.00

Angela Bazigos

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.
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$295.00

Rudy Pina

Reusable Device Cleaning, Disinfection, and Sterilization Validations: Key Design and Compliance Issues as They Pertain to Protocol Development
Validation of reusable medical devices requires that the manufacturer develop methods for cleaning (after use) washing to remove all foreign matter possibly disinfecting and repackaging for the next use.
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$295.00

Dr. Ludwig Huber

Auditing Computer Systems for FDA and International Compliance
This webinar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation.
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$295.00

Markus Weber

Safety Critical Software - Software Risk Management
Using IEC62304 as the internationally recognized software lifecycle standard the risk dependent activities and documentation requirements will be explained.
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$295.00

Jeff Kasoff

Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained
The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF).
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$295.00

Jeff Kasoff

How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with.
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$295.00

Jeff Kasoff

The 510(k) Submission: Requirements, Contents, and Options
This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health.
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$295.00

Anthony G. Tarantino

Supply Chain Risk Management
For the last decade, there has been an extensive and organized effort by organizations to assess their risks, especially in financial services. Non Financial firms are now increasing their risk management especially in the light of such complex, global, and out sourced supply chains. The new ISO 31000 and ISO 31010 frameworks provide guidelines in this process that make good sense and build on years of work by risk professionals.
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$295.00

John Chapman

Verification vs. Validation in Regulated Industries
Attend this webinar to understand the differences and benefits of verification and validation. Learn about the risks and complications involved with the application of sound verification and validation principles.
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$295.00

Dan OLeary

Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans
This course provides the attendees with the tools needed to understand and implement acceptance sampling. We explain the basis for sampling plans, the binomial distribution, and show how it helps us understand the sampling plan's performance using the operating characteristic (OC) curve.
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$295.00

Dan OLeary

Post Market Surveillance for Medical Devices
Post market surveillance is changing, not only in the US, but also in the EU and Canada.
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$295.00

Dan OLeary

Statistical Concepts of Medical Device Process Validation
The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance". The presentation explores the statistical underpinnings of these two phrases. To "fully verify the output" relates to the use of statistical sampling plans, while "high degree of precision" relates to process capability. The presentation illustrates the statistical concepts.
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$295.00

Chinmoy Roy

How to Develop, Monitor and Effectively Communicate your Risk Control Strategy
The intermediate level webinar assumes that attendees are conversant with the basic concepts of QRM. It addresses how to document the results of QRM in a RCS document, techniques to continuously monitor RCS performance and reporting of risk events and remediation to stakeholders. Subsequently, the focus shifts to the development of a process framework to manage risk through activities such as monitoring and communication of the RCS to the diverse group of stakeholders.
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$295.00

Chinmoy Roy

How to Survive a QRM Audit
As QRM tools and techniques become more formalized, regulatory agencies are increasingly requiring companies to establish Quality Risk Management Plans for their operations. Such plans are being used as starting points for regulatory audits. Additionally, to keep in step with the evolution of science and technology, agencies are frequently updating their approach to auditing quality and risk management. This dynamic nature has significantly contributed to an increase in citations. Consequently, companies should become familiar with performing QRM activities that meet compliance requirements.
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$295.00

Steve Jolley

Business Process Optimization in Pharmacovigilance
This webinar will describe how to assess and optimize Pharmacovigilance operations from cost effective, compliance, and safety perspectives. A structured methodology for assessing drug safety operations will be presented. This will include recognizing the need to conduct process analysis, developing and prioritizing project portfolio, performing the analysis, and finally implementing the findings.
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$295.00

Robert J. Russell

South Korea: Navigating the Clinical Trial and Regulatory Environment
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceutical Products in South Korea. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in South Korea. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
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$295.00

David R. Dills

Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements
Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories.
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$295.00

David Lim

Title 21, Code of Federal Regulations for Food and Drugs
United States Food and Drug Administration ("FDA") is the federal agency responsible for ensuring that foods are safe; drugs for human and animals, biologics and medical devices are safe and effective; electronic products that emit radiation as well as cosmetics are safe.
Recorded View Anytime
$295.00

Robert J. Russell

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
Recorded View Anytime
$295.00

David R. Dills

Conducting Successful Product Complaint Investigations
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
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$295.00

Dr. Chitra Edwin

Writing and Maintaining Quality Standard Operating Procedures (SOPs) to Guarantee FDA Compliance
A cogent understanding and thorough knowledge of the regulations for SOPs is a necessity for product development and clinical testing organizations with the goal of agency approval, and product commercialization.
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$295.00

Edwin L Bills

Interfacing Design Verification, Process Validation and Design Validation
There is confusion between the requirements for Design Verification, Process Validation and Design Validation. While each of these processes has its own requirements, they do not stand alone, they are linked together. As this linkage is not well understood, it is the source of FDA observations and potential release of products that do not meet requirements.
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$295.00

Edwin L Bills

Use of Risk Management during Process and Design Validation
In the area of product design, one of the most critical and least understood phases is Design Validation at the interface with Process Validation.
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$295.00

Edwin L Bills

Post-Design Medical Device Risk Management
In this presentation we will explore the requirements for post-design risk management and determine how to apply the requirements.
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$295.00

Markus Weber

IEC62304 - Development and Maintenance of Critical Software
Using IEC62304 as the internationally recognized software lifecycle standard the risk dependent activities and documentation requirements will be explained.
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$295.00

John E Lincoln

"Zero Defects" and the CGMPs - Pros and Cons
U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820).
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$295.00

John E Lincoln

Process Verification and Validation to Meet U.S. FDA Requirements
This webinar will provide valuable guidance to regulated companies in development, implementation, or refinement of their manufacturing process verification and validation programs. It will evaluate validation practices that are more in agreement with ICH Q7 and Q8 than previously accepted validation methods, and will provide thought-provoking questions for FDA-regulated companies.
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$295.00

Angela Bazigos

What to do if you get a FDA 483 Warning Letter
Audits by the FDA are perhaps the most intimidating of all events at a regulated facility. Each year, the FDA conducts several thousand audits, approximately half of which lead to findings that result in Form 483s.
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$295.00

Mark Perkins

Avoiding an FDA Warning Letter with a Strong CAPA Program
The development and implementation of an effective CAPA system is not well understood by many device companies. This webinar is designed to clarify what the FDA is looking for in the CAPA system. Examples of warning letters will be reviewed to understand common themes found by FDA.
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$295.00

Jeff Kasoff

Equipment Validation, Tracking, Calibration, and Preventive Maintenance
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment.
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$295.00

David Lim

510(k) Submissions: Requirements, Challenges and Successful Clearance
A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices.
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$295.00

Anthony DeMarinis

Root Cause Analysis and Documentation Requirements for CAPA
RCA is a popular topic and many companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur.
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$295.00

Anthony DeMarinis

Aspects to Consider for Clean Room Qualification and Operation
Controlled environmental conditions are often used when making medical devices and pharmaceuticals. However, to make sure these clean rooms are continuously operating in a state of control can be a difficult task unless the appropriate controls are incorporated into the design.
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$295.00

Teri C. Soli

Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems
Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.
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$295.00

Teri C. Soli

Water System Biofilm Control and Microbial Monitoring Myths
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
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$295.00

Teri C. Soli

Leadership in Manufacturing Contamination Control
The Microbiology Lab must take leadership in contamination control support for production because it is the hub of the necessary technical expertise.
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$295.00

Dan OLeary

Implementing Management Responsibility for Medical Devices
The FDA's Quality System Regulation (QSR) prescribes the Quality Management System for a medical device manufacturer who markets in the US.
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$295.00

Dan OLeary

Medical Device Supplier Quality Agreements
The FDA’s Quality System Regulation (QSR) explains how a device manufacturer must manage suppliers. This ranges from supplier evaluation and selection to control methods. One common approach uses a supplier quality agreement. This webinar explains the elements of a supplier quality agreement and its implementation.
Recorded View Anytime
$295.00

Steven Walfish

Using Statistics to Determine Sample Size
webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors.
Recorded View Anytime
$295.00

Dan OLeary

Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans
This course provides the attendees with the tools needed to understand and implement acceptance sampling. We explain the basis for sampling plans, the binomial distribution, and show how it helps us understand the sampling plan's performance using the operating characteristic (OC) curve.
Recorded View Anytime
$295.00

John E Lincoln

Device Changes and the 510(k)
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Recorded View Anytime
$295.00

John E Lincoln

DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions
This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/DD requirements, and evaluate the documents' differing purposes / goals.
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$295.00

Dr. Ludwig Huber

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11
In July 2010, the FDA announced to conduct a series of inspections related to 21 CFR Part 11. In meantime the program is still on-going. FDA made it very clear that Part 11 is in effect and will be enforced according to original Part 11 and the guidance from 2003.
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$295.00

Dr. Ludwig Huber

Validation of Analytical Methods for FDA Compliance: Step-by-Step
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.
Recorded View Anytime
$295.00

Dr. Ludwig Huber

IT Infrastructure and Network Qualification: Step-by-Step
Federal laws and regulations mandate to put controls and measures on a company network to ensure security and data integrity. Examples are 21 CFR Part 11, Sarbanes-Oxley Act, and HIPAA. With this legislation IT infrastructure and network qualification and compliance become a much more recognizable issue at higher levels of management.
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$295.00

Dr. Ludwig Huber

Effective Training Practices for FDA Compliance
No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on what the regulations are, their interpretations and expectations of inspectors.
Recorded View Anytime
$295.00

Jeff Schwegman

Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles
This webinar will begin with a discussion of the physical properties of materials that are commonly used to formulate freeze-dried products, and the impact that these materials can have on how products freeze-dry (in regards to the physical and chemical integrity).
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$295.00

David R. Dills

Conducting Successful Product Complaint Investigations
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product.
Recorded View Anytime
$295.00

Jeff Schwegman

Lyophilization Process Development and Cycle Design with a Case Study
This webinar will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle. In the past, a "trial and error" approach was routinely used as the means of cycle design, often resulting in products that were substandard or cycles that were prohibitively long and expensive.
Recorded View Anytime
$295.00

Jeff Schwegman

Residual Moisture Testing of Lyophilized Products
This webinar will cover the various methods used to determine residual moisture in products ranging from bulk powders, to sterile freeze-died products in vials, to foods. Understanding the different techniques, their limitations, and proper execution will result in more accurate and precise moisture results, which translates into better quality products with longer shelf lives.
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$295.00

Jeff Schwegman

Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Products
Lyophilization cycle scale-up and cycle transfer between dryers has traditionally been one of the most challenging issues in manufacturing. Cycles that have been designed on development-scale equipment, and are producing acceptable product, can suddenly start suffering from both physical and chemical instability when scaled-up to a larger freeze-dryer, or transferred between production freeze-dryers.
Recorded View Anytime
$295.00

Jeff Schwegman

Container Closure Systems and Bulk Freeze-Drying
This webinar will start by covering ways to understand the physical properties of our formulated products through the use of very specialized analytical techniques.
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$295.00

David R. Dills

Update on Unique Device Identifier for Device Manufacturers
Recent reports identified several potential benefits to widespread use of UDI, such as reducing medical errors, facilitating recalls, improving medical device reporting, and identifying incompatibility with devices or potential allergic reactions.
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$295.00

David R. Dills

Medical Device Postmarketing Vigilance Reporting: Update and Expectations for Manufacturers
Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5) came into force on January 1, 2008. Providing more guidance than the previous version, the new document includes new reporting terminology and concepts such as "periodic summary reporting" and "trend reporting."
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$295.00

David R. Dills

Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process
A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA.
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$295.00

David R. Dills

Construct and Manage the Technical File and Design Dossier
This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background. The Technical File is a comprehensive collection of information and documents that details everything about your medical device.
Recorded View Anytime
$295.00

Markus Weber

Hazard Analysis vs. FMECA – Differences and Commonalities
The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design.
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$295.00

Jasmin NUHIC

21 CFR PART 11: Complete Manual for Compliance Success
FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to support these activities.
Recorded View Anytime
$295.00

Jasmin NUHIC

Effective Corrective and Preventive Actions (CAPA): 10 Steps
This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success.
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$295.00

Jeff Kasoff

FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes
Marketing wants to entice customers to buy your product instead of your competitor's! A common method is to make the labeling as eye-catching as possible.
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$295.00

Joy Frestedt

Risk-Based Monitoring of Clinical Trials: Say Goodbye to 100% Source Document Verify
The presentation reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
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$295.00

Jeff Kasoff

Process Validation Principles and Protocols for Medical Devices
The benefit of a consistent process is that the yield meets expected criteria. Firms that are able to implement such processes minimize their process rejections and therefore maximize profit.
Recorded View Anytime
$295.00

Jeff Kasoff

Management Controls Under QSR and ISO 13485
The top management of a company is responsible for ensuring that all regulatory requirements are met. This concept is codified in both the QSR and ISO 13485. FDA officials have repeatedly stated that the management controls subsystem is the central subsystem because it is the "glue that holds the quality system together."
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$295.00

Jeff Kasoff

Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements
To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field.
Recorded View Anytime
$295.00

Jeff Kasoff

The FDA Inspection Process: From SOP to 483
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!
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$295.00

John E Lincoln

Lean-Agile Project Management in a cGMP Environment
This webinar is not a project management certification course. It is designed to provide the tools necessary to assist those designing a result or deliverable to achieve that end. It will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
Recorded View Anytime
$295.00

John E Lincoln

Prepare for Tougher cGMP Compliance Audits
This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs.
Recorded View Anytime
$295.00

Steven Walfish

Using Statistics to Determine Sample Size
This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered.
Recorded View Anytime
$295.00

Dr. Efrem H. Zaret

GMP Compliance for Dietary Supplements
The U.S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements.
Recorded View Anytime
$295.00

Steven S Kuwahara

Auditing Analytical Laboratories for FDA Compliance
Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted.
Recorded View Anytime
$295.00

David Lim

Best Practices for Medical Device Reporting (MDR), Recall, Reports of Corrections and Removals
In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident.
Recorded View Anytime
$295.00

David Lim

FDA Compliant Practice for Labeling and Off-Label Communication Through Social Media
This webinar will discuss the FDA's current thinking on good practices for disseminating off-label information by firms for their FDA-approved or cleared products (drugs for both human and animals and medical devices for humans). This webinar will also discuss the FDA proposed and recommended practices for responding to both non-public and public unsolicited requests made through emerging electronic media (e.g., social media or other public electronic media). In addition, several public comments will be discussed in response to the FDA's recent guidance document.
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$295.00

David Lim

How to submit a 510(k) and get it cleared from FDA
This webinar is intended to demonstrate how submit a 510(k) and get it successfully cleared from the FDA.
Recorded View Anytime
$295.00

Steven S Kuwahara

GMP for Phase 1 Products
This presentation will cover the contents of the guidance that was given. FDA has issued as rule that relieves Phase 1 products from complying with the GMP given in 21 CFR 211. At the same time, they ruled that the products must continue to comply with the GMP as given in the Food, Drug, and Cosmetic Act. Guidance was then given to describe these GMP.
Recorded View Anytime
$295.00

Steven S Kuwahara

Statistical Procedures Needed for Compliance with the Guidance on Process Validation
This guidance document contains several statements that make it clear that statistical procedures will be expected. Recently, FDA issued new draft guidance on process validation. When finalized, it will supersede the previously issued guidance documents on process validation. It is expected that the final guidance will not be much different from the draft.
Recorded View Anytime
$295.00

John Chapman

Regulatory Complaint Handling, MDR's & Recalls
Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Webinar will explain the regulatory process and in understandable terms.
Recorded View Anytime
$295.00

Angela Bazigos

Excel Spreadsheet Validation for FDA 21 CFR Part 11
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
Recorded View Anytime
$295.00

Anthony G. Tarantino

Introduction to Financial Risk Management
This 3 hour course of financial risk management will provide the fundamentals to risk management that all managers need to comprehend. Regardless of job titles, risk management is a shared responsibility by all managers.
Recorded View Anytime
$295.00

Jose Mora

Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration
Design Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls. Typically, these cause the creation and maintenance of duplicate information across various documents - a major source of errors. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to avoiding these errors, while presenting a fresh new approach to these key and related documents.
Recorded View Anytime
$295.00

Robert J. Russell

The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectations
This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out effective clinical studies in the U.S. and EU.
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$295.00

Kerry Paul Potter

FDA Inspections - Do's & Don'ts
The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that your products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. The key to a successful inspection is being prepared to communicate how your quality systems assure this state of control.
Recorded View Anytime
$295.00

Kerry Paul Potter

Good Documentation Practices for GMP Operations
Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory employees must follow good documentation practices.
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$295.00

Sylvie Le Glédic

Current Companion Diagnostic Regulatory Framework in the EU & US
This presentation will focus on the major regulatory issues that concerns diagnostic and pharmaceutical partners during co-development of a targeted therapeutic and companion diagnostic.
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$295.00

	Clinical Evaluation Reports (CER's) Required for All Medical Devices in Europe As industry is aware of, now you must deal with the new requirements for Clinical Evaluation Reports (CER's) if you sell all classes of medical devices in Europe. As of March 21, 2010 all medical devices, including Class I and Class IIa, will be required Recorded View Anytime $50.00

	Product Identification and Traceability This webinar will provide valuable assistance to all companies that need to develop and implement Product Traceability Systems. including companies in the produce, meat, and processed food fields. Recorded View Anytime Duration:90 Minutes $294.50

Charles H Pierce

Why is Drug Induced Liver Injury an Important Mirror of Drug Safety
The recent media publicity of the FDA warnings about the OTC drug acetaminophen, which is the most common drug cause for liver transplants, has brought into focus the effects of drugs on the liver.
Recorded View Anytime
$295.00

James Harris

FDA Inspections: What to Expect and How to Prepare
When an FDA agent arrives at the front door of your manufacturing site, he fully expects to be greeted promptly and be given full access to any part of the facility and all records covering manufacturing including raw material specifications, approved su
Recorded View Anytime Duration:60 Minutes
$295.00

Dr. Ludwig Huber

FDA Compliant HPLC Qualification and Performance Testing
Learn how to select, conduct and document the right tests in the right sequence.
Recorded View Anytime Duration:60 Minutes
$295.00

Mark Roberts

Validating Radiation Sterilization for medical device industries
Gamma and E-Beam radiation has used for sterilization of medical devices for over 50 years. Both methods are validated following the same principles and standards.
Recorded View Anytime Duration:60 Minutes
$295.00

Melinda Allen

Foreign Material Control
Establishing HACCP, Preventative and Corrective Maintenance, GMPs and Pest Control programs will reduce foreign material contamination incidences and ensure safe, wholesome, unadulterated products for consumers.
Recorded View Anytime Duration:60 Minutes
$215.00

David Nettleton

Excel Spreadsheet Validation To Eliminate 483s
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.
Recorded View Anytime Duration:75 Minutes
$295.00

David Nettleton

21 CFR Part 11 - Compliance for Electronic Records and Signatures
This webinar details the regulation and how it applies to computerized systems.
Recorded View Anytime Duration:75 Minutes
$295.00

Teri C. Soli

Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems
Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitles
Recorded View Anytime Duration:90 Minutes
$295.00

Albert Cefalo

New Requirements for the Medical Device Directive (MDD)
Back 0n September 5th 2007 the European Union released directive 2007/47/EC (amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning
Recorded View Anytime Duration:60 Minutes
$295.00

Jeff Kasoff

Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage
Virtually all field inspections performed by FDA inspectors are done according to the QSIT.
Recorded View Anytime Duration:60 Minutes
$295.00

James Harris

Process Validation for Drugs and Biologics
Every pharmaceutical manufacturing process is a batch process that consists of discrete steps. Each of these steps involves the use of specific equipment and its operation in a specific manner for a specific length of time.
Recorded View Anytime Duration:60 Minutes
$295.00

Mark Roberts

Design, Planning and conducting Effective audits
Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil.
Recorded View Anytime Duration:60 Minutes
$295.00

Melinda Allen

Specification Development
A good specification not only defines the product and process being purchased by the customer, but also serves as an extension of the purchasing contract.
Recorded View Anytime Duration:60 Minutes
$215.00

Albert Cefalo

The FDA Electronic Submission Gateway (ESG)
With the upcoming mandate by the FDA of the use of their Electronic Medical Device Reporting System (eMDR) all medical device manufacturers will be required to create and submit MDRs via the FDA's Electronic Submission Gateway or FDA ESG.
Recorded View Anytime Duration:60 Minutes
$295.00

Jeff Kasoff

ISO 13485: 2003 - A Straightforward Interpretation with Recommendations for Easy Implementation
Development, implementation, and maintenance of an ISO 13485-compliant quality management system requires many resources and personnel to meet with success.
Recorded View Anytime Duration:60 Minutes
$295.00

Teri C. Soli

Leadership in Manufacturing Contamination Control
The Microbiology Lab must take leadership in contamination control support for production because it is the hub of the necessary technical expertise.
Recorded View Anytime Duration:90 Minutes
$295.00

Dr. Ludwig Huber

FDA's New Enforcement of 21 CFR Part 11
FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations.
Recorded View Anytime Duration:75 Minutes
$295.00

James Harris

Project Management for Phase l & ll Clinical Trials
Before a pharmaceutical product can be approved for marketing in the United States, it must be tested clinically on human patients. Three levels of testing are defined with each level having different goals and number of patients.
Recorded View Anytime Duration:60 Minutes
$295.00

Teri C. Soli

Practical Water System Design and Operation Issues Impacting Biofilm Control
Most people who design, maintain, and monitor high purity water systems have heard of biofilm and a few "rules" about how to control and monitor it.
Recorded View Anytime Duration:90 Minutes
$295.00

Amrish Speaker

Web Test

Recorded View Anytime Duration:15MIn
$0.40

Mark Roberts

Requirements of validation and control of EO Sterilization
Ethylene Oxide (EO) has used for sterilization of medical devices for over 50 years. It is easily the most complicated of the common sterilization methods as it involves the most variables.
Recorded View Anytime Duration:60 Minutes
$295.00

Albert Cefalo

Webinar on Specification Mapping
In order for an organization to satisfy the requirements for Design Control, no matter what Quality Management System (QMS) is being followed, there needs to be traceability from the Product Requirement specification through the verification and validatio
Recorded View Anytime Duration:60 Minutes
$295.00

Jeff Kasoff

Equipment Validation, Tracking, Calibration, and Preventive Maintenance
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment.
Recorded View Anytime Duration:60 Minutes
$295.00

Steven Walfish

Using Statistics to Determine Sample Size
This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data.
Recorded View Anytime
$295.00

James Harris

GMP Auditor Training for Pharmaceutical Companies
Because of the extreme criticality of GMP audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal GMP audits in order to find and correct areas where the firm is not in full compliance with the GMP regul
Recorded View Anytime Duration:60 Minutes
$295.00

Teri C. Soli

Water Microbial Test Methods: Harmonization vs Optimal Quality Control â€“ Your Choice
As much compendial test method harmonization as has already occurred with Microbial Limits testing for non-sterile products and raw materials, surprisingly little has occurred with the microbial test methods used for testing water.
Recorded View Anytime Duration:90 Minutes
$295.00

Albert Cefalo

Introduction to ISO 14971: Risk Management
The term "Risk Based Processes" as become the latest trend in all aspects of medical device design, manufacture, test. distribution or service.
Recorded View Anytime Duration:60 Minutes
$295.00

Peter Calcott

Contract Manufacturing - it requires more than you think to do it right
Overseeing your contract manufacturer is a skill that is better learnt before you make a single dose rather than on the job.
Recorded View Anytime Duration:60 Minutes
$295.00

Melinda Allen

Webinar on Allergen control
Allergens under regulatory control are limited to 8. However, they take on many names and forms. Identifying and avoiding these allergens are an important strategy for manufacturers as well as consumers.
Recorded View Anytime Duration:60 Minutes
$215.00

Jeff Kasoff

Development and Audit of Complaint Handling and MDR Processes
Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control.
Recorded View Anytime Duration:60 Minutes
$295.00

Steven Walfish

Statistical Process Control and Trending Analysis
There are several methods to trend data to highlight both the preventative and corrective nature of the system.
Recorded View Anytime Duration:60 Minutes
$295.00

Albert Cefalo

Management Review: The Complete Requirements
One of the main elements to a fully implemented Quality Management System (QMS) is the Management Review.
Recorded View Anytime Duration:60 Minutes
$295.00

Denise Mainquist

PCI DSS: Tips and Trends for 2010
Compliance to the PCI DSS can be an overwhelming task in the beginning. The requirements are specific and if your organization has not had an information security program in place, there may be a lot to do to meet minimum compliance requirements.
Recorded View Anytime Duration:60 Minutes
$215.00

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