Category Archives: 2026 Training (Jun – Dec)

Effective Root Cause Analysis

DATE: 21 September 2026

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

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

Risk Management for Medical Devices (ISO 14971:2019 / EN ISO 14971:2019/A11:2021)

DATE: 17 & 18 August 2026 (Mon & Tue)

TIME: 9.00am – 5.15pm

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

Medical Device Single Audit Program

DATE: 12 & 13 August 2026 (Wed & Thu)

TIME: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Dorsett Grand Subang Hotel, Selangor
Option 2: Online (via Zoom)

INTRODUCTION
The Medical Device Single Audit Program (MDSAP) was an initiative from the International Medical Device Regulators Forum (IMDRF). Developed to enhance the auditing and monitoring approach of medical devices manufacturing globally, MDSAP went through a 3-year pilot project from 1st January 2014 until 31st December 2016 and became a full program from 1st January 2017.

This MDSAP training provides a comprehensive introduction to the Medical Device Single Audit Program and its regulatory purpose. The course explains the MDSAP framework, audit model, and key requirements, including how MDSAP supports compliance with the regulatory authorities of participating countries. Participants will gain practical insight into audit expectations, preparation strategies, and how to maintain ongoing compliance.

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

• Learn the structure and purpose of Medical Device Single Audit Program (MDSAP)
• Gain a good understanding of the seven processes in MDSAP and their interlinkages.
• Learn the MDSAP audit approach.
• Understand the MDSAP certification process.

COURSE OUTLINE
1. Background of the MDSAP
2. MDSAP members, official observers, and affiliate members
3. The seven processes in MDSAP
4. Chapter 1 – Management
5. Chapter 2 – Device Marketing Authorization and Facility Registration
6. Chapter 3 – Measurement, Analysis and Improvement
7. Chapter 4 – Medical Device Adverse Events and Advisory Notices Reporting
8. Chapter 5 – Design and Development
9. Chapter 6 – Production and Service Controls
10. Chapter 7 – Purchasing
11. Auditing Organization (AO) and MDSAP certification
12. The MDSAP audit approach and audit time determination

EU Medical Device Regulation (EU MDR 2017/745)

DATE: 5 & 6 August 2026 (Wed & Thu)

TIME: 9.00am – 5.15pm

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

INTRODUCTION
The EU Medical Device Regulation (MDR) 2017/745, published on 5 May 2017, introduced a comprehensive framework for regulating medical devices within the European Union. This regulation replaced the EU Medical Device Directive (MDD 93/42/EEC) and the EU Active Implantable Medical Device Directive (AIMDD 90/385/EEC), marking a significant shift toward more stringent and harmonized requirements.

This updated regulation outlines detailed requirements for economic operators — including manufacturers, authorized representatives, importers, and distributors — as well as for notified bodies. In addition to reinforcing existing rules, the EU MDR introduces new and updated classification criteria for medical devices, reflecting the evolving landscape of healthcare and medical technology, and patient safety.

This course will guide participants through the intricacies of the MDR, ensuring they are equipped with the knowledge to navigate the regulatory landscape effectively.

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

• The structure of the EU Medical Device Regulation (EU MDR).
• The general obligations of economic operators.
• The importance of appointing a Person Responsible for Regulatory Compliance, and who can be appointed to the role.
• The additional rules in the EU MDR for medical devices classifications.
• The requirements for risk management process and Technical Documentation (Annex II and III of the EU MDR).
• The requirements for clinical investigation and evaluation.
• The different assessment route in accordance with Article 52.

COURSE OUTLINES
1. Background of the EU Medical Device Regulation and its structure
2. The role and responsibilities of the economic operators
3. Person Responsible for Regulatory Compliance
4. Medical device classification rules
5. Risk management and Technical Documentation
6. Clinical investigation and evaluation
7. Conformity assessment procedures