Corrective and Preventive Action (CAPA) for the Medical Device Industry



Good manufacturing practices are the regulations enforced by the United States Food and Drug Administration (FDA) for medical devices.  Part of these regulations include controls for using a structured process for identifying existing or potential causes of nonconforming product, developing solutions to these problems, and verifying that solutions work.  These regulations are termed “Corrective and Preventive Action” and are referenced in the US Code of Federal Regulations Part 820.100. In this course you will gain an understanding of these regulations and how they work within the quality system to insure that finished devices are safe and effective for their intended uses.



This course is available online, and can be taken at your own pace.

Please note: You must complete the course within 3 months of registration.

Course Features

  • Lectures 0
  • Hands-On Training 0
  • Duration 3 hours
  • Skill level All levels
  • Wet Lab No
  • Max Students 75
  • Assessments Yes