Topics
- Development and contents of an SOP for FDA inspection
- How to prepare for an FDA inspection
- How to behave during an inspection
- Personel training before inspection
- Response to investigation findings
- Limitations of scope of inspection
- FDA guidance documents used by their inspectors
Who should Attend
Delegates from companies that market in the U.S., subject to FDA regulation including Regulatory management, Executive/senior management, Any personnel who may have direct interaction with FDA officials, QA management, Consultants and Quality system auditors.
