15 July 2026 to 2 October 2026: Medtech Professional Certificate in Manufacturing Excellence (ME-Online-2)

Medtech Professional Certificate in Manufacturing Excellence

(ME-Online-2)

DATE: 15 July 2026 to 2 October 2026

TIME: 9.00am – 5.15pm

ONLINE via Zoom

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