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Manufacturing of Medical Devices and Similarly Highly Precise Regulated Products

Training Modules


Module 1: Essential of Lean Manufacturing

  • The philosophy and methodology of Lean Manufacturing
  • Important Lean Manufacturing methods and techniques such as 5S, value stream mapping, mistake-proofing, total productive maintenance, batch size optimisation, layout optimisation, and others
  • A basic Pull scheduling system (e.g. Kanban)
  • Key steps for a successful implementation of Lean Manufacturing
  • Common pitfalls and challenges in implementing Lean Manufacturing


Module 2: A Quality Management System in Compliant to ISO 13485:2003

  •  Insight to the contents and significances of the relevant standards and  regulations.
  •  Prepare the participants to develop or improve; implement or maintain their  organization’s quality management system (QMS).


Module 3: Project Management 101

  • The fundamental PMBOK ( project management (PM) processes, tools and techniques
  • The full spectrum of PMBOK Project Management processes; from initiating, planning, executing, controlling to closing
  • Development of work breakdown structure (WBS) for the entire project
  • Estimation of project cost and schedule using simple and proven techniques (Network Diagrams)
  • Tracking of project performance using Milestone tracking, S-curves, and Earned Value Management (EVM)
  • Handling of project Change Management process effectively
  • Establishing good control, monitoring and effective communication systems



Module 4: Failure Mode and Effect Analysis (FMEA)

  • The different type of failures that can occur in semiconductor devices
  • The underlying physics of the various common failure observed in industry
  • The possible failure mechanisms that will occur for future technology
  • The purpose of reliability tests and their related failure mechanisms



Module 5: Key Aspects of Process Validation of Medical Devices

  • What is a medical device?
  • Why medical devices need to be validated?
  • What are the current regulatory requirements of process validation?
  • What are the typical steps involved in process validation?
  • How to prepare a validation protocols?
  • How to manage a validation project?



Module 6: Application of Statistical Process Control

  • History and concepts of SPC
  • Assumption of control charts
  • Procedure of setting up control charts
  • Calculation of control chart limits
  • Interpretation of control charts
  • Definition of process capability study
  • Capability index
  • Process capability study flow chart
  • Calculation of process capability study



Module 7: Technical Presentation Workshop

Participants will learn how to deliver effective presentation through use of voice, body language and visual aids. A systematic approach will be taught and examples will be given to enhance appreciation.