Category Archives: 2026 Training

NCR/ CAPA/ Complaint Handling

DATE: 2 & 3 December 2026 (Wed & Thur)

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 

Medical Device Manufacturing Process Validation

DATE: 30 Nov & 1 Dec 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 needed to comply with the process validation requirements of the US FDA Quality Management System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program.

COURSE OUTLINE
1. Validation – ISO and regulatory requirements
2. Validation master plan
3. Risk assessment in process validation
4. Statistical tools and techniques
5. Validation system
6. Process validation
7. Software validation
8. Equipment / Software – DQ/IQ/OQ and PQ
9. Change control
10. Validation – Good Documentation Practices

Effective Root Cause Analysis

DATE: 20 November 2026 (Fri)

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

Failure Mode and Effects Analysis (FMEA) in Medical Device Manufacturing

DATE: 18 & 19 November 2026 (Wed & Thur)

TIME: 9.00am – 5.15pm

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

INTRODUCTION
This training course is designed specifically to equip professionals with the knowledge and skills needed to navigate the complex landscape of risk and compliance through an innovative and revamp approach on application of Failure Mode and Effects Analysis (FMEA) with a unified criteria framework. Join us as we delve into practical methodologies that foster a holistic understanding of integrated risk assessment, ensuring effective compliance measures in a dynamic medical device industry.

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

• Learn the practical methodologies for applying reformed Failure Mode and Effects Analysis (FMEA) techniques in diverse business scenarios.
• Gain a deep understanding of the integrated risk landscape and its implications for compliance.
• Learn how to develop a rating table that addresses all pillars of risk.
• Use advance FMEA to determine Critical Product Attributes and Critical Process Attributes for subsequent validation and control activities.
• Develop the ability to identify, assess, and prioritize risks within a unified criteria framework.

COURSE OUTLINE
1. What is FMEA?
2. FMEA history
3. FMEA benefits
4. FMEA challenges
5. When FMEA is needed?
6. Types of FMEA
7. DFMEA vs PFMEA
8. Murphy’s Law
9. Product cycle
10. Terms and definitions
11. Steps in FMEA process
12. Input for DFMEA & PFMEA
13. Process flowchart / map
14. Conventional FMEA weakness
15. Advance FMEA (AFMEA)
16. Understanding & filling of FMEA template
17. FMEA rating & acceptance criteria: Conventional vs. True
18. Pillar of risk – Integrated risk compliance to ISO 13485:2016, ISO 14971:2019, FDA QSR & EU MDR
19. Investigation tools
20. 7 Things on FMEAs
21. Top 10 mistakes made when apply FMEA
22. Relationship between FMEA vs. validation vs. control plan
23. AFMEA for Critical Product Attributes (CPAs) and Critical Process Attributes (CRAs)
24. List of other risk assessment tools & techniques