Topics
- Development and contents of an SOP for FDA inspection
- How to prepare for an FDA inspection?
- Reliance of FDA inspectors on other external sources
- Reliance of FDA inspectors on compliance program guide manuals
- In depth review and summary of QSIT
- Personnel training before inspection
- Use of QSIT for internal auditing
Who should Attend
Attendees from Diagnostic, Medical Device, Biologics and Pharmaceutical fields, including Regulatory Management, Executive/Senior Management, Any personnel who may have direct interaction with FDA officials, QA Management, Quality System Auditors and Consultants.
