Category Archives: 2026 Training (Jun – Dec)

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

Statistical Process Control and Capability Analysis

DATE: 17 November 2026 (Tue)

TIME: 9.00am – 5.15pm

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

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

• Differentiate the different data types.
• Understand process variation and process stability.
• Select, analyse, and interpret control charts.
• Differentiate the different types of process instability.
• Select the appropriate method to determine the current process capability.
• Using Minitab software for process control and capability analysis.

COURSE OUTLINE
1. Discrete data and continuous data
2. Minitab navigation
3. Determine process capability
4. Identify process instability and develop improvement strategies
5. Use the right control chart

ISO 13485:2016 Quality Management System

DATE: 16 & 17 November 2026 (Mon & Tue) 

TIME: 9.00am – 5.15pm

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

INTRODUCTION
ISO 13485:2016 is the internationally recognized Quality Management System (QMS) standard specifically developed for organizations involved in the design, manufacture, installation, and servicing of medical devices. It places strong emphasis on regulatory compliance, risk-based thinking, process control, and continual improvement to ensure the safety, performance, and reliability of medical devices throughout their lifecycle.

This training provides participants with a practical and structured understanding of ISO 13485:2016 requirements, focusing on how the standard is applied in real manufacturing and quality system environments. The course bridges the gap between standard requirements and day-to-day operations, helping organizations establish, implement, maintain, and improve an effective medical device QMS.

Through interactive discussions, real-life examples, and industry best practices, participants will gain clarity on key QMS elements such as management responsibility, resource management, risk management, product realization, supplier control, documentation, internal audit, CAPA, and regulatory alignment. The training is designed to support organizations in achieving compliance with global regulatory expectations, and improving operational effectiveness.

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

• Understand the key requirements and intent of ISO 13485:2016.
• Recognize how ISO 13485 applies to daily work activities in the medical device industry.
• Understand and interpret the ISO 13485:2016 requirements.
• Learn the practical implementation examples.

COURSE OUTLINE
1. Introduction of ISO 13485:2016
2. 7 Quality Management Principles
3. Clause by clause interpretation of ISO 13485:2016

• Clause 0: Introduction
• Clause 1: Scope
• Clause 2: Normative References
• Clause 3: Terms and Definitions
• Clause 4: Quality Management System
• Clause 5: Management Responsibility
• Clause 6: Resource Management
• Clause 7: Product Realization
• Clause 8: Measurement, Analysis and Improvement