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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: Axel Wirth, National Healthcare Solutions Analyst for Symantec, brings an expert perspective to the issue of protecting devicemakers’ data from hacking and other cyber threats. Wirth covers:
The evolution of cyber threats;
FDA recommendations for medical devices;
Security systems available to the industry; and
Resources and references devicemakers can turn to for more information.
Description: Noted QSR expert Dan O’Leary provides a soup-to-nuts examination of controlling nonconforming product problems to avoid FDA sanctions and recalls. From an in-depth look at QSR requirements to inspection preparation, O’Leary covers:
The five steps involved in handling nonconformance problems;
Training personnel to identify and deal with problems;
Types of disposition of nonconformance problems; and
Description: Top drug development consultant Hoss Dowlat illustrates some of the many pitfalls in new EU pharmacovigilance regulations regarding medication errors using real-world case studies. Dowlat covers:
Differences between an Adverse Drug Event and an Adverse Drug Reaction and what should be reported in the EU;
Product design to minimize medication errors;
Proactive risk assessment guidance from the FDA and the EMA; and
Description: Hoffman LaRoche/Genentech veteran Ken Schiff demonstrates how to use quality risk management principles, electronic data capture and other IT systems to monitor clinical trial sites remotely. Topics include:
Automatic analysis of existing data that allows continuous risk management;
Description: Pharmatek’s Bryan Knox explains his company’s strategy for making sure the chemistry and manufacturing section of a drug application will pass FDA muster. Knox outlines a “scorecard” model that assesses: