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The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.
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If you are already a Training Pass member login below and then scroll down to view the list in date order or narrow your search by keyword or category. Viewing the webinar is easy… simply identify the webinar you want to watch, click on the title and the video will begin. If you would like to view or download the presentation materials separately from the video click the "Download Presentation" link.
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Description: Consultants Dean Cirotta and William Ment cite the most common GMP deficiencies found in dietary supplement manufacturing and the best way to handle FDA inspections. This presentation provides:
An overview of FDA inspections and regulatory actions;
Review of the FDA’s compliance program for dietary supplements;
What the agency considers the major deviations that often result in warning letters; and
Strategies for responding to warning letters and 483s.
Description: Environmental monitoring expert Kenneth Christie provides explanations of regulatory requirements for EM programs, facility design, personnel training and aseptic technique. Christie also covers:
Description: Supplier management expert John Avellanet covers regulatory requirements for data management, supplier validation review,SOPs and records closeout. He answers important questions regardingthe:
Interrelationship between 21 CFR Parts 11 and 820;
FDA enforcement trends; and
How “paper audits” can be the first foundation for a strong compliance program, and how to identify which records to retain and required SOPs.
Description: Speakers Olga Marchenko and Seth Berry of Quintiles, Inc. present 10 reasons to use adaptive designs in dose-ranging studies and 10 benefits of modeling and simulation in drug development. Topics include:
Theory and methods in adaptive design;
Algorithm-based designs vs. model-based designs; and
Future view of model-based design’s impact on the biopharma industry.
Description: Attorney Kurt Karst of FDA Law Blog explains how the FDA’s unapproved drug enforcement options have changed since the agency revised its Compliance Policy Guide to allow action at any time without prior notice and without regard to prior enforcement policies. To aid drugmakers, Karst presents:
Six priority areas the FDA is pursuing;
A decision tree for deciding whether or not a drug is considered unapproved by the FDA; and
Description: An overlooked requirement within the Quality System Regulation (QSR) is quickly moving up the audit checklist of FDA investigators. QSR Section 820 doesn’t mention the word “trend,” but the FDA has demonstrated in 483s and warning letters that it expects companies to analyze and trend their quality data — and then act on what they’ve learned. But most companies don’t know the scope of the requirements, let alone how to react to them. Is yours one of them?
Speaker: James Eric Miller, Core Quality Systems Senior Quality Analyst, Roche Diagnostics