Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data

Event Information
Product Format
Prerecorded Event
Presenter(s)
Jeff Kasoff, RAC, CMQ/OE, LBB
Conference Date
Wed, Apr 05, 2017
Length
60 minutes
Product Description

Understand the Importance, Requirements, and Elements of a Robust CAPA Program


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 enables both regulatory compliance and cost savings.

Most complaints include terminology that is unlikely to withstand an FDA or ISO audit, such as “isolated occurrence” and “low risk.” Further, from a business perspective, how do you let your customers know that you received their complaint, when you know that their next question may be the dreaded “What did you find out?” A compliant quality system has, as one of its supports, a robust complaint system that is both complaint and business-savvy.

This webinar by expert speaker Jeff Kasoff, RAC, CMQ/OE, LBB, will address all of the issues mentioned above and discuss the importance, requirements, and elements of an effective CAPA program. Jeff will also describe the uses of CAPA data and the application of risk management to a CAPA program, including a specific risk management system.

Jeff will help you identify the most common elements identified as deficient by FDA, and provide recommendations for how to provide clear, concise documentation to assure FDA that your firm has addressed these in your quality system. Additionally, you’ll receive recommended forms to assure that in addition to being able to illustrate compliance, your firm’s CAPA system is useful and meaningful.

Session Highlights:

  • Regulatory Requirements
    • FDA QSR
    • ISO 13485
  • Elements of a cross-procedural CAPA program
  • Applications of CAPA
  • CAPA Data, and best practices for its use
  • Application of risk management to CAPA program

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:

  • QA Management
  • CAPA Coordinator
  • Regulatory Affairs Management
  • Executive Management
  • Consultants
  • Quality System Auditors

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Jeff Kasoff

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...   More Info
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