17-18 November 2025: NCR/ CAPA/ Complaint Handling

NCR/ CAPA/ Complaint Handling

DATE: 17-18 November 2025

TIME: 9.00am – 5.15pm

VENUE: Ascott Gurney Hotel, Penang

DURATION: 2 full-day course

COURSE OBJECTIVES
This course introduces the concepts needed to understand the requirements of nonconformance
(NCR), corrective action preventive action (CAPA) & complaint handling under ISO 13485:2016 QMS
and US FDA Quality System Regulation (21 CFR Part 820). It also provides guidance on how to address
each of them effectively with a step-by-step process.

COURSE OUTLINE
1. Standard and regulatory perspective on NCR, CAPA and Complaint Handling
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

CONTACT
For enquiries, please email to Medsociate Sdn Bhd
Authorised training provider of AMMI
Email: learning@ammi.com.my / admin@medsociate.com
Tel: +6012 539 4194