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Corrective and Preventive Action (CAPA) Explained

Summary

  • Regulatory Requirements

  • Correction vs. Correction Action

  • CAPA & Risk Management

  • Determining Root Cause

  • Tools for Root Cause Analysis

  • Corrective Action Effectiveness

  • Quality System Trending

  • Linking CAPA to other parts of the QMS (Quality Management System) 

Overview

Corrective and Preventive Action (CAPA) is a requirement under international standards such as ISO 13485:2016, ISO 9001:2015 and FDA under 21CFR 820 & is typically found in FDA Warning Letters.

This webinar will define and explain Corrective Action and Preventive Action requirements as found in ISO 13485 and FDA requirements. It will include discussions on root cause analysis, quality system trending, corrective action effectiveness, and how CAPA is critical to be linked to other parts of the quality system including customer complaints, manufacturing nonconformities, customer feedback, supplier performance, etc.  Lastly, this course will include the consequences of poor adherence to these pro

Why should attend?

  • Quality & Regulatory Professionals
  • Manufacturing & Design Engineers
  • Marketing Product Managers
  • Corporate & Operations Executives

John Chapman

Expert

John Chapman, BS, MBA, RAC has over 35 years medical device regulatory experience and over 15 years experience with the European Union’s medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. RAB Accredited Lead Auditor Course Certificate1996. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. 

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