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JUMP DIRECTLY TO SLIDE The FDA Inspector Cometh FDA What has happened at UMHS FDA Inspection History at UMHS FDA Inspection History at UMHS (2) Who conducts inspections? Office of Regulatory Affairs FDA Field Investigators Who and What are inspected? Who? What studies? What is the inspection process 1. FDA Selects Sites Reasons: For Cause Inspections 2. FDA Investigator Contacts site 3. FDA amd Site Agree on Visit date Preparation Tips for Site Examples Preparation Tips for Site 4. FDA presents Notice of Inspection 5. FDA Requests data and documents Tips on Document Requests 6. FDA Interviews Site Staff Tips for Anticipating FDA Questions Tips for handling FDA Questions 7. FDA conducts Exit Interview 8. FDA Presents notice of observations Most Common Observations 9. FDA writes inspection Report 10. FDA classifies inspection FDA Office / Site Location Diagram Audience Question Audience Answer Audience Question Audience Question Audience Question Audience Question Audience Question Audience Question        synchronize audio with current slide