CAPA Execution Under QMSR

Build a CAPA system that regulators trust and teams can execute with consistency. 

This self-paced course provides practical, regulator-aligned guidance on designing, maintaining, and executing an effective Corrective and Preventive Action (CAPA) process under ISO 13485:2016 and the FDA Quality Management System Regulation (QMSR). 

Across five focused lessons, the course explains how CAPA functions as a closed-loop system that connects data analysis, risk-based decision making, investigation discipline, cross-functional action planning, and effectiveness verification. You’ll learn when CAPA is required, how to document defensible decisions, how to structure investigations, and how to demonstrate effectiveness in a way that stands up to audit and inspection. 

This course is designed for quality, regulatory, and operational leaders who need CAPA to operate as a reliable system record—one that reflects sound judgment, clear ownership, and sustained control. 

At a Glance 

• Total Length of Course: 1 hour  

• RAC Points: 1 point 

• This course was developed by Michelle Lott and Tianna Benson from LeanRAQA 

Learning Objectives 

Upon completion of this course, participants should be able to: 

• Understand CAPA expectations under ISO 13485:2016 and FDA QMSR 

• Apply risk-based decision making to CAPA initiation and routing 

• Use data analysis and investigation tools to identify defensible root causes 

• Build clear, cross-functional action plans with documented approvals 

• Verify effectiveness and document sustained outcomes that hold up in audit/inspection 

Lesson Titles 

• Lesson 1: Back to Basics: CAPA 

• Lesson 2: FDA & CAPA Then and Now 

• Lesson 3: CAPA Considerations 

• Lesson 4: How to CAPA 

• Lesson 5: CAPA Effectiveness Verification 

• Lesson 6: Common Pitfalls & Best Practices 

This course is also included in: