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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: Leading legal analysts Erika Lietzen and Laura Sim deconstruct the FDA’s biosimilars guidance and the comments it received and what FDA enforcement and emphasis might look like in the future. They also highlight important areas the guidance doesn’t address, such as:
Pediatric testing; and
When a regulated entity should construct its own defensible compliance programs instead of waiting for overt FDA direction.
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.