How FDA Trains Its Investigators to Review CAPA and Best Practices for Preparation
  • CODE : JEKA-0018
  • Duration : 60 Minutes
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Jeff Kasoff, RAC, CMQ/OE, LBB, has more than 30 years 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 startup 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 primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.


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 section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as straightforward proven recommendations on how your company can use that same document in your preparation.

Learning Objectives

  • Documents Used by FDA Inspectors
  • Operations Manual (IOM)
         o CAPA Implications, by Section
             1. Requirements
             2. Recommended Methods of Compliance for Each Requirement
  • CPG Manual 7382.845
         o CAPA Implications, by Section
            1. Requirements
            2. 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

Who Should Attend

This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • CAPA Coordinators
  • Executive Management
  • R&D Management
  • Regulatory Management
  • QA Management
  • Consultants
  • Quality System Auditors

  • $200.00



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