Share and learn ... What’s new and what to expect before, during, and after inspections/audits.
- Know what to expect regarding inspections?
- Decide whether to go into the “MDSAP” program?
- Cope with unusual expectations/questions/behaviors/demands?
- Decide who should (and who should not) meet with the Inspectors?
- When do MDSAP findings automatically become FDA “OAI”s?
- Handle the Opening Meeting, the Closing Meeting?
- After the Inspection: Responses? 483s/Annotations? EIRs? FOI?