Please join David Burrow from FDA's Center for Drug Evaluation and Research as he discusses key opportunities for the clinical research industry to make their FDA inspection experience a positive one. Dr. Burrow will outline the impact inspections have on marketing applications and will identify key strategies to build quality into clinical research in order to prevent critical compliance issues. When problems do occur, inspected entities should be able to respond appropriately. In this session, you will be able to take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence.
This presentation is a webinar replay from the ACRP Conference Library
Speaker: David Burrow, PharmD, JD
Director of the Office of Scientific Investigations (OSI)
Center for Drug Evaluation and Research (CDER)
FDA
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