Corrective and Preventive Action (CAPA)

Sep 22, 2021 - 01:00 PM EST
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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

Areas Covered in the Session:

·      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) 

Who Will Benefit:

Companies wishing to understand the risks and complications involved with a solid system of corrective action to document & resolve serious issues found in every medical device firm that can affect the bottom line.    Employees who will benefit include:

  • Quality & Regulatory Professionals
  • Manufacturing & Design Engineers
  • Marketing Product Managers
  • Corporate & Operations Executives
Webinar Events
Attend Live Webinar
Sep 22, 2021 - 01:00 PM EST

Duration: 60 Minutes

Single Attendee

Group of 3 to 5

Group of 6 to 10

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

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