Description
Join FDA personnel from the Center for Drug Evaluation and Research as they discuss key opportunities for the clinical research industry to make their FDA inspection experience a positive one. The speaker will outline recent inspection trends and 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. Take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence.
Learning Objectives:
- Identify recent trends in CDER-BIMO inspections of clinical investigators, sponsors, and IRBs.
- Describe key strategies for building quality into clinical trials.
- Describe key strategies for responding to FORM FDA 483s and Warning Letters.
Speaker(s):
- David
Burrow,
PharmD, JD,
Director of the Office of Scientific Investigations (OSI),
Center for Drug Evaluation and Research, FDA
- Karri
Venn,
RD, CDE, CCRC,
President, Research,
LMC Manna Research
