CAPA  - Corrective and Preventative Action Requirements Medical Device Manufacturing and Design Training

CAPA: Corrective and Preventive Action Requirements and Industry Practice

Year after year, one of the top reasons cited by the FDA in 483s is “lack of or inadequate procedures” for CAPA. This course will give you the knowledge you need to eliminate warnings due to CAPA-related issues.

This 2-day course provides intensive coverage of the elements of a corrective and preventive action (CAPA) system. Some primary topics include the purpose of a CAPA system and how it is integrated throughout a Quality Management System; appropriate data sources and how to coordinate, analyze and manage them; methods for verifying and validating actions; how to write good CAPA plans; how risk management is used in conjunction with the CAPA system; and 21 CFR and ISO 13485 requirements. 

Learning Objectives:
  • Experience intensive coverage of the elements of a CAPA system
  • Learn the purpose of a CAPA system and its integration throughout a quality management system (QMS)
  • Identify appropriate data sources and how to coordinate, analyze, and manage them
  • Learn methods for verifying and/or validating actions
  • Practice writing good CAPA plans
  • Learn the use of risk management in conjunction with the CAPA system
  • Familiarize yourself with 21 CFR 820 and ISO 13485 requirements

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at

For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-US addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email


”Having insightful faculty who have seen a variety of industry practice was very valuable. Additionally, I thought including the linkages to other quality systems, specifically management review, was a nice addition to just talking about the actual CAPA process. It is really a benefit in the FDA attending the course as well as providing some of the training.”

– Recent Course Attendee




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