How FDA Trains its Investigators to Review CAPA and What Should You do to Prepare
  • CODE : JEKA-0027
  • Duration : 60 Minutes
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Jeff Kasoff, RAC, CMQ/OE has more than 30 years of experience in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.

Jeff has also been the primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE. He is also a certified internal auditor for MDSAP, ISO 13485:2016, and EU MDR, from Exemplar Global.

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 the FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with. Also contained in this session will be a 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.

Areas Covered

  • Documents Used by FDA Inspectors
  • Operations Manual (IOM)
         o CAPA Implications, by Section
              -    Requirements
              -    Recommended Methods of Compliance for Each Requirement
  • CPG Manual 7382.845
         o CAPA Implications, by Section
              -    Requirements
              -    Recommended Methods of Compliance for Each Requirement
  • QSIT Manual
         o Description of each CAPA Inspectional Objectives
         o Description/explanation
         o Recommended Methods of Compliance

Course Level - Intermediate

Why Should You Attend

CAPA is the most cross-functional of all subsystems of your QMS. Firms have different CAPA processes which utilize different definitions and terminology for the same meanings. Having advanced knowledge and awareness of what to expect during the FDA inspection will drastically assist your firm in the ability to anticipate the inspector’s questions, and how to “translate” your CAPA system into what the inspector is looking for.

  • $200.00

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