This course will deal with the following content:
| 1. Definition of PAI, FDA objectives | 10. Clinical trial material GMPs |
| 2. FDA Expectations | 11.Process validation |
| 3. Assignments/targets | 12. Implementing success steps |
| 4. Objectives | 13. PAI Team |
| 5. Field Actions | 14. PAI Preparation |
| 6. Critical success factors | 15. Items for examination |
| 7. Key procedures | 16.Actual Inspection |
| 8. Key to successful PAIs | 17.Inspection aftermath |
| 9. Quality Systems needed |
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