Medical device inspections from FDA can be a nail-biting experience. However, with the right preparation and due-diligence, you can be prepared for any situation. In this course, the instructor will provide an “insider’s guide” of tips, examples and advice for specific areas where FDA inspectors will focus their inspection efforts related to the 31 sections of the 21 CFR Part 820 Quality System regulation.
- FDA’s approach to conducting inspections
- How FDA prioritizes their inspections
- 7 major & minor sub systems of QSIT
- Types of FDA inspections
- Which documents FDA cannot request
- “Back room” preparation for the inspection
- FDA 483s – Wording & Trends