"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

Compliance Seminars®

Medical Device equipment

Effective Corrective Action and Preventive Action
– for Medical Device Industry

Course description:

This course provides you with the knowledge and confidence to interpret the Corrective and Preventive Action requirements in ISO 13485:2016 and the US Food & Drug Administration’s Quality System Regulation.

Over two days, you will learn the key requirements for medical device Corrective Action and Preventive Action (CAPA), explore key concepts, and consider options for implementing effective CAPA.

Course objectives:

  • Review and discuss ISO 13485:2016’s and FDA’s Corrective and Preventive Action requirements.
  • Identify key aspects of an effective CAPA process.
  • Compare investigation approaches, and resulting action planning and implementation.
  • Evaluate options for determining effectiveness of CAPAs.
  • Understand how CAPA fits in the Quality Management System.
  • Explore typical auditor questions and intent regarding CAPA.

Course content:

  • Purpose of a CAPA system
  • Identifying issues proactively
  • Reactive issue identification
  • Corrections vs Corrective Actions
  • CAPA process for addressing issues
  • Conducting investigations to identify root causes
  • Action planning for success
  • Confirming CAPA effectivity
  • Relationships in the QMS: Complaint Handling & Nonconforming Product
  • CAPA Records
  • Key considerations for a successful audit

Note: This course is presented electronically. Each attendee must bring their own laptop to the course venue; course materials are provided electronically, and Adobe PDF Reader is essential to fully participate in the course.

Who should attend:

Intended for professionals with some knowledge of medical device or combination product Quality Management Systems. This course is ideally suited to staff needing a broad perspective on CAPA, including Research & Development, Engineering, Manufacturing, Quality, Regulatory, and internal quality auditors.


When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
Watch this short video to learn more about what Gate2GMP® offers »

Make an enquiry


Make an enquiry  


Course facts

Course no:
Medical Device industry

GMP region:
US and Global

Tammy Pelnik
Ms. Tammy M. Pelnik,
St. Vrain Group, Inc.

Date, location and venue:

This course is only offered in-house.
Click here for more info and inquiry form.

We offer a public one day CAPA course with Tammy Pelnik :
Essential Corrective Action and Preventive Action Practices

2 days