FDA Inspections: Simulated Environment of a Clinical Trial Response Team What Would You Do?

Join us for our virtual workshop where we will provide an overview of what to expect and how to respond to an audit or FDA inspection and use real case scenarios in an interactive format to help solve the dilemmas faced by both sites and industry when faced with discoveries from regulatory authorities or auditors. You participate from the comfort of your office or home, with all the benefits of workshop activities, but no travel necessary.

Steps for response and follow up actions will be explained. Interactive exercises will be incorporated utilizing FDA Warning Letters. Participants will learn how to perform root cause analysis (RCA) and prepare corrective and preventive actions (CAPAs). Learn how to answer completely and effectively to avoid further actions by regulators.

• Janet E. Holwell, CCRC, CCRA, TIACR, Consultant