Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data
  • CODE : JEKA-0040
  • Duration : 60 Minutes
  • Level : Intermediate
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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.

This webinar will identify the most common elements identified as deficient by FDA, and provide recommendations for how to provide clear, concise documentation to assure FDA your firm has addressed these in your quality system. This webinar also provides recommendations to assure that in addition to being able to illustrate compliance, your firm’s CAPA system is useful and meaningful.

CAPA is the most cross-functional of all subsystems of the QMS. It is fraught with potential pitfalls and nonconformances, all of which will be addressed in this session:

  • The distinction between corrective and preventive action
  • Assuring all types of data are captured in CAPA
  • The importance of assuring root cause investigation
  • Understanding CAPA closure and the pitfalls in the establishment of KPIs
  • Documenting CAPA implication when CAPA is not implemented
  • Adequacy of assuring CAPA effectiveness

Learning Objectives

  • Applicable Regulations
  • Contents of Procedure(s)
  • Definitions
  • Elements of a CAPA program
    – Detection of nonconformance
    – Identification of cause (Investigation)
    – Review of Investigation
    – Determination of Corrective/Preventive Action
    – Performance of Corrective/Preventive Action
    – Implementation of Corrective/Preventive Action
    – The effectiveness of Corrective Action
  • Summary

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 and D Management
  • Regulatory management
  • QA management
  • Consultants
  • Quality system auditors

Why Should You Attend

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enable both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program, as well as describing the uses of CAPA data. Additionally, the application of risk management to a CAPA program will be reviewed, and a specific risk management system detailed. This session will cover all the items listed above, and more. If you want to improve your CAPA system, you cannot afford to miss this.

  • $179.00

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