How FDA Trains Its Investigators to Review CAPA, and Best Practices for Preparation


Jeff Kasoff is Keynote Speaker at Compliance key Inc. Jeff Kasoff, RAC, CMQ/OE, Lean Black Belt, 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 quali....

Overview

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. 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 techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, 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 how your company can use that same document to increase the likelihood of a positive outcome during the inspection.

Why should you attend this webinar?

CAPA is the most cross-functional of all subsystems of the QMS. Firms have different CAPA processes which utilize different definitions and terminology for the same meanings. Having advance 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.

Areas Covered in the Session:

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

Who can Benefit:

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



Webinar Id: LSHCHJK004

Training Options:

Duration: 60 mins

 06/20/2017

 12.30 PM PST | 03.30 PM EST

 Single Attendee: [Only for one participant]

 $179 (Live)                    $304 (Live + Recorded)

 Multiple Attendee: [For a group of 2-5 participants]

 $363 (Live)                    $488 (Live + Recorded)

 Corporate Attendee: [For a group of 6-10 Participants]

 $726 (Live)                    $945 (Live + Recorded)

 Recorded: [Six month unlimited access]

 $217(Single Attendee)  $599 (Unlimited Attendee)

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