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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.
PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!
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.
Select webinars have been pre-approved by RAPS as eligible for up to 1.5 credits toward a participant’s RAC recertification. Please enter keyword RAPS below for a list of eligible on-demand webinars.
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
Description: Kevin Eskew and Lisa Murtha of SNR Denton Healthcare Group discuss the impact of Medicare policies on clinical trial billing and explain how to negotiate a clinical trial budget that keeps your sites operating and billing in compliance. Information presented includes:
Which costs are billable to third-party payers;
Strategies for managing billing and risk reduction; and
Requiring development and use of Medicare Coverage Analysis at the beginning of the planning stage.