By the end of this presentation, participants will have an understanding of how the FDA's Bioresearch Monitoring (BIMO) program conducts inspections, including recent changes to the FDA’s processes, and be able to create a plan for managing an inspection by the FDA. Speakers will share their experiences from the perspective of an IRB, a CRO, and a research site.

Participants will be able to be develop a process for inspection management that includes communication with FDA, developing a communication chain for the inspection, and addressing any outcomes related to the inspector’s findings.