Category Archives: 2026 Training (Jun – Dec)

Medical Device Quality System: ISO 13485:2016 & US FDA Quality Management System Regulation

DATE: 19 & 20 October 2026 (Mon & Tue)

TIME: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Iconic Marjorie Hotel, Penang
Option 2: Online (via Zoom)

INTRODUCTION
The medical device regulatory landscape is evolving toward global alignment. With the release of the US FDA Quality Management System Regulation (QMSR), which formally incorporates ISO 13485:2016 by reference, manufacturers now face a harmonized quality system framework that supports compliance across both U.S. and international markets.

This training provides a comprehensive understanding of ISO 13485:2016 requirements and the new US FDA QMSR (21 CFR Part 820), highlighting how these two systems are interconnected. Participants will gain insight into the key similarities, differences, transition expectations from the previous US FDA Quality System Regulation (QSR) to the new QMSR model, and best practices for inspection readiness. Through structured explanations, the course will help participants build practical knowledge on how to apply both ISO 13485:2016 and US FDA QMSR requirements effectively in their quality management systems.

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

• Understand the structure, purpose, and intent of ISO 13485:2016 as a quality management standard for medical devices.
• Interpret ISO 13485:2016 requirements clause by clause.
• Understand the key functions and roles of the US FDA in medical device regulation.
• Overview of FD&C Act and CFR.
• Prepare for FDA inspections and audits.
• Understand key highlights of the new Quality Management System Regulation (QMSR).

COURSE OUTLINE
1. Introduction of ISO 13485:2016
2. 7 Quality Management System Principles
3. Clause by Clause Interpretation of ISO 13485:2016
4. Introduction of US FDA

• The US Food and Drug Administration (FDA)
• The Federal Food, Drug, and Cosmetic Act (FD&C Act)
• The Code of Federal Regulations (CFR)
• Importance of Compliance with US FDA QMSR

5. FDA Inspection

• Introduction
• FDA Inspection Flow
• Quality System Inspection Techniques (QSIT)
• Medical Device Quality System: ISO 13485:2016 & US FDA Quality Management System Regulation
• Preparation and Expectation
• FDA Inspection Outcome
• Response to FDA Observations/ Form 483

6. Quality Management System Regulation (QMSR)

• Introduction
• Overall Highlight of Main Changes
• Summary of Key Changes
• QSR vs QMSR Section Comparison
• QMSR Section by Section Requirements Interpretation
• Executive Summary for Medical Device Manufacturer

Medical Device Change Control

DATE: 12 & 13 Oct 2026 (Mon & Tue)

TIME: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Iconic Marjorie Hotel, Penang
Option 2: Online (via Zoom)

COURSE OBJECTIVES
This course provides quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills to implement change control for medical devices.

COURSE OUTLINE
1. Introduction to design control
2. Application of risk management to design control
3. Design control system

• Design and development planning
• Design and development input
• Design and development output
• Design and development review
• Design and development verification
• Design and Development validation
  
• Design and development transfer
• Design and development changes
• Design history file

4. Validation system (Design/Installation/Operational and Performance Qualification)
5. Statistical tools and techniques
6. Design control – Quality system inspection technique

Medical Device Design Control

DATE: 28 & 29 September 2026 (Mon & Tue)

TIME: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Iconic Marjorie Hotel, Penang
Option 2: Online (via Zoom)

COURSE OBJECTIVES
This course provides quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills to implement design control for medical devices.

COURSE OUTLINE
1. Introduction to design control
2. Application of risk management to design control
3. Design control system

• Design and development planning
• Design and development input
• Design and development output
• Design and development review
• Design and development verification
• Design and Development validation
• Design and development transfer
• Design and development changes
• Design history file

4. Validation system (Design/Installation/Operational and Performance Qualification)
5. Statistical tools and techniques
6. Design control – Quality system inspection technique

COURSE FEES (8% SST Included)

Option 1: Iconic Marjorie Hotel, Penang
Early Bird Price (until 7 Sep 2026)
AMMI Member: RM 1,998.00
Public: RM 2,214.00

Normal Price (from 8 Sep 2026)
AMMI Member: RM 2,214.00
Public: RM 2,430.00

Option 2: Online (via Zoom)
Early Bird Price (until 7 Sep 2026)
AMMI Member: RM 1,652.40
Public: RM 1,868.40

Normal Price (from 8 Sep 2026)
AMMI Member: RM 1,868.40
Public: RM 2,084.40

Bonus deal for group registration
For the 6th pax to 9th pax: 30% discount
For the 10th pax & above: 75% discount

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

Effective Root Cause Analysis

DATE: 21 September 2026 (Mon)

TIME: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Iconic Marjorie Hotel, Penang
Option 2: Online (via Zoom)

INTRODUCTION
Root Cause Analysis (RCA) is one of the most common actions required at every organisation, not only to solve day-to-day operational problems but also to play an important role in other improvement activities such as lean sigma, risk management, etc. Root cause analysis involves searching backwards from an undesirable effect (or problem) to its cause(s) and addressing those causes to effectively prevent recurrence.

This training provides the learner with a basic understanding of the principles and techniques of effective root cause analysis and providing concepts needed to effectively perform investigation.

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

• Understand the principles and techniques of effective root cause analysis.
• Recognise common barriers to root cause analysis and apply techniques to overcome those barriers.
  

COURSE OUTLINE
1. Challenges in root cause analysis
2. Benefits of effective root cause analysis
3. Symptoms vs cause of the problem
4. Contributing factor vs root cause
5. Types of root cause
6. Root cause analysis problem solving model
7. Root cause analysis tools
8. Actions to prevent future problem – corrective action preventive action
9. Human error
10. Root cause analysis in a regulated environment
11. Tips for performing effective root cause analysis

NCR/ CAPA/ Complaint Handling

DATE: 7 & 8 September 2026 (Mon & Tue)

TIME: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Iconic Marjorie Hotel, Penang
Option 2: Online (via Zoom)

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