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How FDA Trains Its Investigators to Review CAPA, and What You Can do to Prepare
Event Details
Time: June 21, 2012 from 10am to 11am
Location: Online Event
Street: 2600 E. Bayshore Road
City/Town: Palo Alto
Website or Map: http://www.complianceonline.c…
Phone: 16506203915
Event Type: online, training
Organized By: Referral
Latest Activity: May 22, 2012
Event Description
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.
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.
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