Research 9A – FDA Inspections: Always Be Ready and What to Do When They Actually Come Knocking on Your Door!
Paul Papagni, Executive Director of Research, Holy Cross Hospital Trinity Health
- Learn from other people’s mistakes: Common findings from 483s, FDA warning letters, and trends
- Learn from the Compliance Program Guidance Manual: Instructions for conducting FDA inspections
- Before, during and after inspection: What you need to know and what you need to do to prepare