The FDA Inspection: Preparation, Management, and Follow-Up 2015 is a webinar that covers topics such as:
- 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
The FDA Inspection: Preparation, Management, and Follow-Up 2015 is intended for attendees from medical device, diagnostic, pharmaceutical, and biologics fields, including:
- Regulatory management
- Executive/senior management
- Any personnel who may have direct interaction with FDA officials
- QA management
- Quality system auditors
- Consultants