/Jeff  /Kasoffspeaker of compliance global
Speaker: Jeff Kasoff

Duration: 60 Minutes
Product Code: 700713
Level: Intermediate

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

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Overview

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.

Why Should You Attend

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 recommended forms to assure that in addition to being able to illustrate compliance; your firm’s CAPA system is useful and meaningful.

Areas Covered in this Webinar

  • 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

Learning Objectives

This CAPA compliance training 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 will be explained.

Who Will 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:

  • QA management
  • CAPA coordinator
  • Regulatory Affairs management
  • Executive management
  • Consultants
  • Quality system auditors

Speaker Profile

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 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.

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Training Options
Duration: 60 Minutes

This webinar is currently unavailable.Please contact customer support on +1-844-746-4244 for training options that we could offer you and further details about this listing.