Category Archives: Uncategorized

Medtech Professional Certificate in Manufacturing Excellence

(ME-Penang-1)

DATE: 13 April 2026 to 3 July 2026

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang and Iconic Hotel, Bukit Mertajam, Penang

DURATION: 10-full-day course

COURSE DESCRIPTION / OBJECTIVES
The Medtech Professional Certificate in Manufacturing Excellence aims to enhance the knowledge and skills of current employees in medical device manufacturing operation. They will learn about product life cycle management and how to improve the operation system by eliminating waste, improve current process through process mapping, comply with process validation requirements, use statistics to validate assumptions and root causes, identify process instability and develop improvement strategies, evaluate the quality of measurement systems, determine the relationship between factors affecting a process & address non-conformances and product complaint.

TARGET PARTICIPANTS:
This course aims to train manufacturing professionals.

COURSE OUTLINE
1. Lean Manufacturing (2 days)

• The operational ‘waste’ (The 7 lean wastes)
• Lean best practices

2. Process Mapping (1 day)

• Process mapping tools and process analysis tools
• Strategies to improve current ‘as is’ process

3. Medical Device Manufacturing Process Validation (2 days)

• Validation Master Plan
• IQ , OQ & PQ

4. Hypothesis Testing (1 day)

• Hypothesis testing with comparative methods
• Correlation and regression analysis

5. Statistical Process Control and Capability Analysis (1 day)

• Control charts
• Methods to determine the current process capability

6. Measurement System Analysis (1 day)

• Gage repeatability and reproducibility
• Attribute agreement analysis

7. Design of Experiments (1 day)

• Factorial design and analysis for experimentation
• Process model for process prediction and simulation

8. NCR / CAPA / Complaint Handling (1 day)

• Standard and regulatory perspective
• Step-by-step process to address non-conformance, CAPA and complaint

Medtech Professional Certificate in Quality Assurance

(QA-Penang-1)

DATE: 31 March 2026 to 26 June 2026

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang

DURATION: 10-full-day course

COURSE DESCRIPTION / OBJECTIVES
The Medtech Professional Certificate in Quality Assurance aims to enhance the knowledge and skills of current employees in quality management system. They will learn how to ensure compliance with the latest US FDA Quality Management System Regulation (QMSR) and EU Medical Device Regulation (EUMDR), develop proper risk management documentation, address and handle non-conformances and product complaint, perform effective investigation to get to the root cause of a problem & manage incoming and outgoing inspection using acceptance sampling method.

TARGET PARTICIPANTS:
This course aims to train quality assurance professionals.

COURSE OUTLINE
1. Medical Device Quality System: ISO 13485:2016 & US FDA Quality Management System Regulation (2 days)

• Interpretation of the ISO 13485:2016 and QMSR requirements
  
• FDA inspection – The expectation and preparation
  

2. EU Medical Device Regulation (EU MDR 2017/745) (2 days)

• Classification rules of medical devices
• Technical documentation (Annex II & III of EU MDR)
• Conformity assessment procedures

3. Risk Management for Medical Devices (ISO 14971:2019 / EN ISO 14971:2019/A11:2021) (2 days)

• EN ISO 14971:2019/A11:2021 requirements
• Risk management tools

4. NCR / CAPA / Complaint Handling (2 days)

• Standard & regulatory perspective on NCR, CAPA & complaint handling
• Step-by-step process to address non-conformance, CAPA and complaint

5. Effective Root Cause Analysis (1 day)

• Principles and techniques of effective root cause analysis
• Common barriers to root cause analysis and techniques to overcome it

6. Acceptance Sampling Method (1 day)

• Selection of a suitable acceptance sampling plan
• Designing a sampling plan