CAPA and root cause analysis, tools for an effective CAPA process

Note. Changed date: March 24th, 2026

Drowning in CAPAs?
This one-day online course is your lifeline. Learn how to turn your CAPA system from a reactive burden into a proactive engine for improvement. You’ll gain practical insights into regulatory expectations under ISO 13485:2016, EU MDR/IVDR, and FDA Quality System Regulation, 21 CFR Part 820 (QSR)—and how to meet them with confidence.

Learning benfits

• Interpret CAPA requirements in ISO 13485:2016, EU MDR/IVDR, and FDA QSR.
• Apply root cause analysis tools to identify and eliminate systemic issues.
• Plan, implement, and verify corrective and preventive actions that stick.
• Transform your CAPA system into a driver for risk management and continuous improvement.
• Understand how CAPA links with other QMS elements for better efficiency and compliance.

Course outline

• CAPA System Fundamentals
  Understand the scope, purpose, and regulatory context of CAPA systems under ISO 13485:2016, EU MDR/IVDR, and FDA QSR.
• Risk-Based CAPA Decision Making 
  Learn how to evaluate data sources and decide when to initiate CAPA using a risk-based approach.
• Root Cause Analysis Tools 
  Apply practical tools and techniques to identify root causes and prevent recurrence of issues.
• Action Planning & Effectiveness Checks 
  Develop and verify corrective and preventive actions, and ensure they are effective and sustainable.
• CAPA System Management & Integration 
  Discover how to move from reactive firefighting to proactive learning and improvement, and how CAPA links with other QMS elements.

Who should attend

This course is ideal for professionals involved in operating or auditing a Quality Management System for medical devices, especially those responsible for planning, executing, and monitoring CAPA activities

Prerequisites

• You should have completed a basic or intermediate course in medical device quality systems or have equivalent internal training.
• You should have at least 2 years of experience in the medical device industry.

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