Topics
- Development and contents of an SOP for FDA inspection
- How to prepare for an FDA inspection
- How to behave during an inspection
- Personnel training before inspection
- Response to investigation findings
- Limitations of scope of inspection
- FDA guidance documents used by their inspectors
Who should Attend
Attendees from Diagnostic, Medical Device, Biologics and Pharmaceutical companies in the US, including Regulatory management, Executive/senior management, Any personnel who may have direct interaction with FDA officials, QA management, Quality system auditors and Consultants.
