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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: Legal experts Laurie Clarke and Lynette Zentgraft provide an overview of three important 510(k)-related guidances designed to make review of premarket submissions more efficient. Topics include:
Definition of “eCopy;”
Changes in acceptance review checklists for 510(k)s; and
Description: Consultant Kenneth Christie explains the most important aspects of developing and maintaining a compliant program, with a special emphasis on cleaning. He also provides insights on what the FDA expects of such a program, including:
Establishment of schedules for frequency;
Establishment of defined procedures and methods to be used;
Description: Industry analyst Dan O’Leary discusses why management with executive authority has the responsibility to create and maintain a Quality Management System. He also addresses other important QMS components, including:
Description: Compliance expert Barbara Godlew explains how to develop an institutional/company policy on trial data disclosure and how to create effective SOPs. Other hands-on practical tips include how to:
Consider software for creating/routing/uploading disclosure records;
Verify new informed consent letters for applicable clinical trials; and
Adjust compliance strategies for international trials for which the researcher is the sponsor/responsible party.
Description: Attorney James Wood explains how the FDA views potential recall scenarios and how it differentiates between a recall situation and a less serious clarification. Wood identifies what should be in a recall report and how to present that information, including:
Number of consignees notified of the recall, and date and method of notification;
Number of consignees responding to the recall communication and quantity of products on hand at the time it was received;
Number of consignees that did not respond; and
Number of products returned or corrected by each consignee contacted and the quantity of products accounted for.