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

CAPA and Root Cause Analysis – Tools for an Effective CAPA Process

Tired of “death by CAPA”? This course shows you how to transform your CAPA system from reactive firefighting to a powerful tool for improvement. Learn to interpret the CAPA requirements in ISO 13485:2016 and FDA QSR, apply root cause analysis tools, and manage actions effectively. Through real-life examples and exercises, you’ll gain practical insights into how CAPA can support risk management and strengthen your QMS.

What You’ll Learn:

· CAPA requirements in ISO 13485:2016 and FDA QSR

· Identifying CAPA sources and using a risk-based approach

· Root cause analysis methods

· Planning and verifying corrective and preventive actions

· Linking CAPA to other QMS processes

Who Should Attend:

Professionals responsible for CAPA systems or QMS audits

Staff working with CAPA planning, execution, and follow-up

Prerequisites:

At least 2 years of experience in the medical device industry

Basic knowledge of quality management systems

Instructor:

Åse Ek, Senior Consultant at GBA Key2Compliance – over 20 years of experience in MedTech and Pharma, with deep expertise in QA/RA, post-market surveillance, and regulatory compliance.