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Recorded Webinar

How FDA Trains Its Investigators to Review CAPA, and What You Can do to Prepare

timelapse 60 mins with 10-15 mins of Q and A

Note:

This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times

Speaker/Presenter

Short Abstract

During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with. Also covered in this session will be a section-by-section summary of the CAPA subsection 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.

The presentation will cover the following areas:

  • Documents Used by FDA Inspectors
  • CAPA Implications of Investigations Operations Manual (IOM), and Recommended Methods of Compliance for each Requirement
  • CAPA Implications of CPG Manual 7382.845, and Recommended Methods of Compliance for each Requirement
  • QSIT Manual: Description of each CAPA Inspectional
  • Objective, and Recommended Methods of Compliance


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