8 – 9 June 2026: NCR/ CAPA/ Complaint Handling

NCR/ CAPA/ Complaint Handling

DATE: 8 & 9 June 2026

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang

DURATION: 2 full-day course

INTRODUCTION
This course introduces the concepts needed to understand the requirements of NCR, CAPA and complaint handling under ISO 13485:2016 QMS and US FDA Quality Management System Regulation (21 CFR Part 820). It provides guidance on how to address each of them effectively with a step-by-step process that incorporates root cause analysis & problem-solving tools. 

COURSE OBJECTIVES
After participating in the training, you will be able to:

• Understand requirements: Learn the key regulations and standards on managing NCR, complaint, and CAPA in the medical device industry.
• Handle NCR effectively: Identify, document, and manage nonconformances to maintain product quality.
• Improve complaint handling: Develop skills to investigate and resolve customer complaints efficiently.
  
• Strengthen CAPA process: Implement corrective and preventive actions to prevent recurring issues.
• Ensure compliance: Build systems that meet regulatory requirements and improve operational performance.
  

COURSE OUTLINE
1. Standard and regulatory perspective on NCR, complaint handling and CAPA
2. Nonconformance process flow
3. Tips to prevent nonconformance
4. Sample template for nonconformance
5. How to write an effective nonconformance report
6. Complaint handling process flow
7. Rules of complaint handling
8. Tips for effective complaint handling
9. Sample template for complaint handling
10. Differences between correction, corrective action, and preventive action
11. Steps to create risk-based CAPA process
12. Sample template for CAPA