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Customer Testimonials

Nice response to my questions and good suggestions for moving forward.

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.

Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.

Featured Speakers

Steven S Kuwahara

Founder & Principal,

GXP Biotechnology, LLC

Roy E Costa

President,

Environ Health Associates, Inc.

Dr Laura Brown

QA Consultant,

Live Webinars

36 webinars found.

Live

Jerry Dalfors

Maintaining a Validated State - PV, PM and Statistics associated with Current Regulations
Statistical Applications - Use of a statistician or person with adequate statistical training (not just 6 Sigma) to develop the experimental design and the statistical methods / models needed to measure and evaluate process capability, uniformity and on-going stability.
Live Wednesday, June 19, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes
$199.00

David Lim

Medical Device Adverse Event Reporting in EU, US and Canada
Medical device firms' obligation doesn't end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable.
Live Thursday, June 20, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$225.00

Angela Bazigos

FDA's 21 CFR 11 Add-On Inspections - Recent Updates
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.
Live Thursday, June 20, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:2 Hours
$245.00

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. Your goal is to get the 510(k) through the review process as quickly as possible.
Live Thursday, June 20, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$245.00

Melinda Allen

Webinar on BRC Risk Analysis
Risk Assessment is a fundamental and intuitive activity that is not new to manufacturing professionals. Bringing consciousness and tangibility to this process is the challenge often faced. A practical guide documenting the process will be the topic of this training.
Live Wednesday, June 26, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$165.00

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. High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual".
Live Wednesday, June 26, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$245.00

Kerry Paul Potter

Do's & Don'ts during FDA Inspections
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. The key to a successful audit is being able to communicate how your quality systems assure this state of control.
Live Wednesday, June 26, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$225.00

David R. Dills

Complaint Handling and Management: From Receipt to Trending
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.
Live Thursday, June 27, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes
$225.00

David Lim

FDA-Compliant Medical Device Design Control
Understanding, interpreting, and implementing design control requirements in a holistic manner can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment.
Live Thursday, June 27, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$199.00

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. The manufacturer must also compile records of the production history of the device. These two sets of records (DMR & DHR) are complimentary.
Live Tuesday, July 9, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes
$245.00

David Lim

Current Good Manufacturing Practice for Medical Devices Including IVDs
This webinar is intended to help you get familiar with the current Good Manufacturing Practice (cGMP) for medical devices including in vitro diagnostic medical devices. This webinar is further intended to provide guidance on the cGMP requirements set out in the Quality System Regulations (QSRs), which help assure that medical devices are safe and effective for their intended use.
Live Tuesday, July 9, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$225.00

David R. Dills

Draft Guidance for Device Industry and FDA - Postmarket Surveillance
This guidance document is being distributed for comment purposes only and will be of benefit for medical device manufacturers and the document was issued on August 16, 2011. Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act) is one means by which the Food and Drug Administration (FDA) can obtain additional safety and/or effectiveness data for a device after it has been cleared through the premarket notification (510(k)) process or approved through the premarket approval application (PMA), humanitarian device exemption (HDE), or product development plan (PDP) process, when it is necessary to protect the public health. Postmarket surveillance is not a substitute for obtaining the necessary premarket information to support 510(k) clearance or PMA, HDE, or PDP approval.
Live Tuesday, July 9, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$225.00

John E Lincoln

Compiling the Design History File, and Technical File / Design Dossier
This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD. It will discuss the major sections of both, common elements and differences, what must be included and what should be included, and how the information should be compiled and presented.
Live Wednesday, July 10, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$245.00

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. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
Live Wednesday, July 10, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$225.00

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).
Live Thursday, July 11, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$245.00

Angela Bazigos

How to Select Software for a Regulated Environment
Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?
Live Thursday, July 11, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:2 Hours
$245.00

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. Questions like: how much detail is required in the requirement specification? What is a software unit? How can integration testing be performed without test harnesses? will be answered. Practical guidance on how to employ a streamlined but yet compliant development process will be given.
Live Tuesday, July 16, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$225.00

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.
Live Tuesday, July 16, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:75 Minutes
$245.00

Kosta Makrodimitris

Unique Device Identification (UDI): Upcoming FDA Rules, Requirements and Timelines for Industry and Hospitals
US-FDA has released a proposed rule (2012) that most medical devices distributed in the United States carry a unique device identifier (UDI). Congress passed legislation in 2007(FDAAA) directing the FDA to develop regulations establishing a UDI system for medical devices.
Live Wednesday, July 17, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes
$225.00

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. Out of ignorance, it is too easy to over-react with numerous activities only to find that the problem returns because the root cause was not squarely addressed.
Live Thursday, July 18, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes
$225.00

David Nettleton

Excel Spreadsheets - Develop and Validate to Eliminate 483s
Learn how to Use excel spreadsheet for GXP data and reduce validation cost and time. Configure Excel for audit trails, security features, and data entry verification.
Live Thursday, July 18, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$245.00

Robert J. Russell

European Union Filings and Registrations
This session covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States, as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.
Live Tuesday, July 23, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes
$245.00

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? Determine which Center will review my combination or non-combination product?
Live Tuesday, July 23, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes
$225.00

David Lim

FDA 510(k): Preparation, Submission, and Clearance
This webinar is intended to demonstrate how to prepare a 510(k), submit, and get it cleared in a manner with increased quality so that the review process can be expedited. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices.
Live Tuesday, July 23, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$225.00

John E Lincoln

Risk-based Software Verification and Validation
The FDA, GAMP and others provide guidance in the methodology and documentation to achieve this. Consideration of the principles in ISO 14971 can assist in providing an acceptable vehicle by which to perform and document risk-based software V&V. 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.
Live Wednesday, July 24, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$245.00

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.
Live Thursday, July 25, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$245.00

Melinda Allen

HACCP Validation and Verification
HACCP elements of the Codex Alimentarius required by GFSI auditing schemes. The process by which the HACCP program is tested.
Live Thursday, July 25, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$165.00

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. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.
Live Thursday, July 25, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:2 Hours
$245.00

Robert J. Russell

New EU Pharmacovigilance Directive and Regulations
New Legislation & Guidance for Pharmacovigilance will apply in the European Union (EU) beginning July 2012. To assist in its implementation with sponsors, applicants and license holders, a series of Guidance Documents is being written, which will replace the current set of Volume 9A of the Rules Governing Medicinal Products in the EU. The legal framework for pharmacovigilance on Medicinal Products for Human Use has now been updated, through an amended EU Regulation (No 1235/2010) and Directive (2010/84/EC).
Live Tuesday, July 30, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes
$245.00

Kerry Paul Potter

Root Cause Analysis
This course provides clarification of the competencies to plan effective, efficient and thorough investigations and design a process for the successful elimination of recurring failures and deviations.
Live Tuesday, July 30, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$225.00

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. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project.
Live Tuesday, July 30, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$245.00

Dan OLeary

Process Validation for Medical Devices
Process validation is a powerful technique to help you find the point where your process should operate. In addition, it can help you find the limits of the process. These limits, applied to the process inputs define the parameter space that produces satisfactory process output.
Live Wednesday, August 7, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes
$245.00

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.
Live Tuesday, August 13, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$245.00

David Lim

Medical Device Complaint Handling Systems
This webinar is intended to demonstrate how to adequately establish and maintain medical device complaint handling systems. All medical device manufacturers are required to comply with the complaint handling requirements. Understanding the relevant and applicable requirement can significantly contribute to achieving compliance and remaining compliant, resulting in saving significant amount of time and efforts in business while ensuring the safety and effectiveness of the medical device products.
Live Wednesday, August 14, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes
$199.00

Robert J. Russell

The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND
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.
Live Tuesday, August 20, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes
$199.00

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. Participants will gain a solid understanding of how the OC curve is built, how to use it, and how to identify some of the most important points on the curve, including the AQL and RQL points.
Live Wednesday, August 28, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes
$245.00

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