This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.
The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance is not good, it is not the show that may close, it is YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!
- Does the FDA call in advance or just show up at my door?
- Where do I let the inspector go?
- Do I give them a tour?
- What should I let them see?
- Who should I let them talk to? Are they ever going to leave?
Areas Covered in the Session:
Who Will Benefit:
- How to prepare for an FDA inspection
- Development and contents of an SOP for FDA inspection
- Personnel training before inspection
- How to behave during an inspection
- What to show FDA during an inspection
- Proper Post-inspection Follow-up
- Limitations of scope of inspection
- Response to investigation findings
- FDA guidance documents used by their inspectors
- Internal / External Auditors
- Regulatory Management
- Quality Assurance Professionals
- Sales/Marketing Management
- Senior and mid-level Management
- Quality System Auditors