Clinical Training 2011 - Clinically-Related 483's and Warning Letters: Getting through the Maze

This webinar on Clinically-Related 483's and Warning Letters will show how you can manage clinical site FDA inspections, handle issues, understand and respond to observations ("483") and/or Warning Letters.

FDA inspections of clinical trial sites, sponsors and IRBs have yielded observations (reported on FDA Form 483, or “483’s) and Warning Letters. Understanding the fundamentals of the FDA Biomedical Research inspections is critical in order to ensure that any observations and any subsequent regulatory action are dealt with appropriately and completely.

By the end of this webinar, the participant will have an understanding of the context for clinical site FDA inspections and the issues that may arise. Effective handling of these issues during the inspection can reduce the risk of further regulatory action. Should observations (“483”) and/or a Warning Letter be issued, participants will have an enhanced understanding how and the timing required to respond, and how to avoid further regulatory action by the Agency.