
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
DURATION
Two (2) full days
MODE OF TRAINING
Classroom Training
COURSE FEES (8% SST included)
Early Bird Price (until 27 October 2025)
Member: RM 1,998.00
Public: RM 2,214.00
Normal Price (from 28 October 2025 onwards)
Member: RM 2,214.00
Public: RM 2,430.00
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