Albert A. Ghignone

FDA's Expedited Programs for Serious Conditions - Drugs and Biologics

This webinar covers FDA's 4 programs to facilitate and expedite development and review of new drugs/biologics to address unmet medical needs in the treatment of a serious or life-threatening condition. The 4 FDA programs are Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation and Accelerated Approval.

Angela Bazigos

FDA's 21 CFR 11 Add-On Inspections - Recent Updates

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.

Teri C. Soli

Laboratory Water Systems: Necessary Water Specifications and Validation Challenges

Laboratory water systems are often the forgotten, red-haired stepchild of pharmaceutical operations. Yet, in some ways, the maintenance of the appropriate quality of lab water systems is perhaps more important than many applications of manufacturing's water systems since the tests performed on manufacturing's products can be affected by the lab water quality in insidious, hard to detect ways, which could cause perfectly good products to appear to fail testing or bad product to appear to pass. Often too little effort is invested in understanding and maintaining lab water systems for a number of reasons that will be discussed. On the other hand, excessive effort may be expended in maintaining certain water attributes that are neither required nor consequential for the vast majority of analyses, such as the microbiological content.

Kim Huynh-Ba

Effective CAPA Program for GMP Operations

Having an effective CAPA documentation and tracking system are crucial to pharmaceutical operations. This system will allow personnel to identifying the root cause, corrective action taken, and verification stages.

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.

David Nettleton

21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits

This webinar details both regulations and provides details for implementing computerized systems. Learn exactly what is needed to be compliant for all three primary compliance areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach.

John N. Zorich

Normality Tests and Normality Transformations: Explanations, Justifications, and Uses

Normality Tests and normality transformations are a combination of graphical and numerical methods that have been in use for many decades. These methods are essential to apply whenever a statistical test or method is used whose fundamental assumption is that the inputted data is normally distributed.

David R. Dills

Establish and Maintain an Effective Supplier Qualification Program

FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct (as it relates to your product). FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns.

Robert F. Munzner

Obtaining an FDA Investigational Device Exemption

Clinical testing and studies of effectiveness are often needed to demonstrate that new medical devices are reasonably safe and effective. The participation of human subjects in these studies often implies some degree of risk and outcomes which are necessarily unpredictable. It is essential, therefore, that the rights, safety, and welfare of the subjects be protected. The instrument by which this is accomplished is the Investigational Device Exemption (IDE).

Heath Rushing

Ensuring Process Control and Capability

Process control is concerned with product quality result remaining stable, consistent, and predictable over time. Process capability is concerned with product quality results remaining within predetermined specifications over time.

Karl Leinsing

Secrets of Successful Medical Device Product Development Process

We will give you the steps and information to develop a medical device product. The documentation discussed can also be used and is often requested by the FDA and required by many ISO procedures for controlling the design process.

Jim Polarine

Current Industry Best Practices in Disinfectant Validation

Designing an effective disinfectant validation program to meet FDA, MHRA, HPRA, EMA scrutiny. This webinar provides guidance on industry trends, regulatory feedback, and designs for an effective validation program. Current 483's, Warning Letters, European Regulations, and Field Experiences as well as case studies will be conveyed that allow end users to determine that best methods to validate their products against their environmental isolates. Current industry best practices will be covered as well as potential pitfalls that can occur during testing.

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.

Susan Rocca

Quality Management Systems - Creating, Implementing and Improving

Today's manufacturers face enormous challenges managing their quality and compliance initiatives. Market trends point to even greater scrutiny of these efforts as pressure mounts from both consumers and regulatory agencies for manufacturers across a broad range of industries to deliver better, safer products and services. To meet these important regulatory challenges, it is imperative that manufacturers have a quality management system to manage processes and provide timely access to relevant data, effectively and efficiently.

Kim Huynh-Ba

Impact of Good Documentation Practices on Compliance Activities

Key components of documentation and record management system will be introduced. Regulatory requirements will also be discussed as the basis of documentation standards. It will also cover different types of records and how it would affect quality systems.

John N. Zorich

Better Alternatives to Sampling Plans

The webinar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans. The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Michael Brodsky

Root Cause Analysis

Root Cause Analysis seeks to identify the origin of a problem.

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.

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?

Melinda Allen

BRC Risk Analysis

Risk Assessment is a fundamental and intuitive activity that is not new to manufacturing professionals.

Charles DeLeon

Growing a Compliance Program in Government Contracting

The Federal Government is a huge bureaucratic-type of organization, with a lot of moving parts, that serve different functions spread out around the world. Within this large structure, it has complex processes built upon numerous requirements that companies seeking to contract with the US Government must follow. To ensure that they are complying with the various contractual, regulatory and statutory requirements expected from government contractors, most, if not all large and mid-size government contractors devote personnel and resources to perform compliance functions to reduce the exposure to penalties and other consequences.

Michael Brodsky

The Enigma of a Healthy Diet

The difficulty of developing and validating reliable analytical approaches will also be discussed. There is need for reliable data to address public health issues associated with produce. There are no harmonized criteria or method classification system to assist laboratories in choosing appropriate methods.

Dr. Ludwig Huber

Quality by Design (QbD) for Development and Validation of Analytical Methods

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data evaluation and report generation. Regulations such as FDA's GxPs, 21 CFR Part 11 and the EU-PIC/S Annex 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality.

Heath Rushing

Quality by Design: Establishing a Systematic Approach to Pharmaceutical Development

This webinar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles. In addition, this webinar teaches the application of statistics for setting specifications, assessing measurement systems, developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents.

John N. Zorich

Statistical Analysis of Gages (Metrology)

The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios". Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage Linearity, and Gage Bias.

Albert A. Ghignone

21CFR Part 58 - The Good Laboratory Practices (GLP) Regulation

FDA regulates the nonclinical safety testing of Drugs, Biologics and Medical Devices under a regulation called The Good Laboratory Practices (GLP)regulation. This webinar will address the reasoning for and the requirements of the GLP regulation. Every section of the GLP (Subparts A - Subpart K) will be addressed. FDA's "umbrella" approach to the GLP will also be discuss and FDA interpretations of the GLP reviewed.

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. Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via a PMA supplement without prior FDA approval only when such modifications are based on newly acquired information and evidence of a causal association between the product and a safety signal is present.

Albert A. Ghignone

The 510(k) Program: Substantial Equivalence In Premarket Notifications (510(k))

FDA developed this document to provide guidance about current FDA review practices for premarket notifications – 510(k) submissions. FDA's intent is to identify, explain and clarify each of the critical decision points in the 510(k) decision making process FDA uses to determine substantial equivalence.

Susan Rocca

Differences Between API and Product Manufacturing - Points to Consider when Auditing

The development of the modern pharmaceutical industry through the 20th and 21st centuries has been accompanied, or in some case followed, by the development of controlling legislation and guidelines. The focus of this control has historically been greatest for pharmaceutical dosage forms. This is perhaps not unreasonable, these products are closest to the patient and are historically where most, and the most significant, problems have occurred.

Albert A. Ghignone

The FDA Drug Development Process

This webinar provides an overview of the FDA's Drug Development Process. This webinar also includes the major FDA regulations involved in the Drug Development Process - the GLP, GMP and GCP regulations.

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.

Albert A. Ghignone

Drug Approval: The FDA IND-NDA System

This webinar presents an overview of the entire FDA Drug Approval Process. The webinar addresses FDA requirements from discovery to USA marketplace. The webinar begins by developing a molecule, testing it, going through the IND process, human clinical testing and then the NDA process.

David Nettleton

Efficient Computer System Validation - 10 Easy Steps

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.

John E Lincoln

Product Hazard Analysis and Risk Management Under ISO 14971 and FDA, ICH Q9

This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 and Q9 models to perform and document such activities for any medical product. It will examine the additional actions necessary to make it a useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and training tool, and how to maintain it as a "living document".

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.

Heath Rushing

Using Design of Experiments (DOE)for Product-Process Development

Prior to developing a process control plan as part of an overall risk management strategy, process development studies must be completed. The objective of these process development studies is to gain knowledge and understanding about how variation in process parameters explains variation in the product quality characteristics of the product.

John N. Zorich

Confidence-Reliability Calculations and Statistically Valid Sample Sizes

Next, detailed descriptions are given for how to calculate confidence/reliability for data that is either pass/fail (i.e., "attribute" data), normally-distributed measurement data, non-normally distributed measurement data that can be transformed into normality, or non-normally distributed measurement data that cannot be transformed into normality.

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. This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

John E Lincoln

The Master Validation Plan - The Unwritten 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.

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. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices.

Steven S Kuwahara

GMP Perspectives on Working with Contracting Laboratories

When working with contract testing laboratories, clients must remember that the responsibility for compliance with the GMP or the GLP ultimately lies with the product sponsor. Even if the contract assignes the responsibility to the contract laboratory, the responsibility for assuring compliance lies with the client. Neither can the contract laboratory assume that the client has complied with their responsibilities.

Dr. Ludwig Huber

FDA Compliant HPLC Qualification and Performance Testing

High Performance Liquid Chromatography is the most frequently used analytical tool for pharmaceutical and API testing laboratories. FDA and international agencies require HPLC equipment to be calibrated, qualified and tested to ensure accurate and reliable analytical results. Even though this is well known since long time, laboratories are unsure on what exactly should be tested initially and on an on-going basis.

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. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

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.

David Nettleton

GxP Computer System Validation, The investigator's Point of View

The webinar explains what is needed to prepare for an audit or regulatory inspection. It addresses SOPs for the GxP and IT infrastructure, hardware and software qualification, computer system validation, and change control for revalidation. This event is applicable to regulated companies and software vendors.

Robert J. Russell

The European Clinical Trial Directive (EUCTD)

The course also covers recent updates on EU GCP associated with the Directive, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators.

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".

John E Lincoln

Change Control - Key to Successful cGMP Compliance

There is a continuing pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its change control policies and systems.

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.

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.

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.

Robert J. Russell

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.

Robert Kunka

Developing an Efficient Relationship with FDA

Some pharmaceutical companies do not have the experience in the regulatory area which includes knowledge of the process, needs, and results necessary for a company to be productive at the regulatory agency. Just as a couple dances together, the pharmaceutical company "dances" with the regulatory agency. Neither of the partners wants to step on the feet of the other.

John E Lincoln

Device Changes, FDA 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. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

Dan OLeary

Device Corrections and Removals

When your firm finds a problem with one of the devices you already shipped, fix it for the customer. Do you report it to the FDA?

Steven S Kuwahara

GMP Expectations for Products Used in Early Phase IND Studie

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.

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