Name
Communicating with the FDA: How to Facilitate an Inspection Post-COVID
Date & Time
Friday, November 18, 2022, 9:15 AM - 10:00 AM
Description
The pandemic has created a slowdown in inspections, particularly with inspections of sites outside the U.S. The FDA has recently resumed “normal operations” with respect to inspections but sites that are not deemed mission-critical by the FDA may still find themselves stuck in a long queue, waiting for an inspection. This session will focus on how to communicate with the FDA regarding when your site might expect an inspection and in what circumstances you can provide information (and what information you can provide) that might make that inspection happen sooner rather than later.
Speakers
Mark Schwartz - Hyman Phelps
Grace McNally - Greenleaf Health, Inc.
Kalah Auchincloss - Greenleaf Health
Grace McNally - Greenleaf Health, Inc.
Kalah Auchincloss - Greenleaf Health
Track
Plenary
Location Name
Gallery 2-3