How FDA Trains Its Investigators to Review CAPA, and What You Can do to Prepare
Thursday, June 21, 2012 from 10:00 AM to 11:00 AM (PDT)
Palo Alto, CA
This CAPA investigation training webinar will discuss FDA’s techniques to do CAPA inspection, what the FDA tells their inspectors to focus in the QSIT document and how your company can use the QSIT document to prepare for inspection.
This session will discuss what the FDA tells their inspectors, and how they train them, including a detailed analysis of the CAPA training.
What should I expect the FDA investigator to look at when they visit? The FDA inspection can be much easier to handle and manage if you know what to expect. Advance knowledge will enable you to prepare for the FDA inspection. This knowledge and planning will make the inspection experience much less stressful, and assure better compliance. This session will discuss what the FDA tells their inspectors, and how they train them, including a detailed analysis of the CAPA training. Also contained in this session will be a section-by-section summary of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document in your preparation.
This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.
Areas Covered in the Seminar:
- How to prepare for an FDA inspection?
- Development and contents of an SOP for FDA inspection.
- Reliance of FDA inspectors on compliance program guide manuals.
- Reliance of FDA inspectors on other external sources.
- Personnel training before inspection.
- In depth review and summary of QSIT.
- Use of QSIT for internal auditing.
When & Where
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