Medtech Upskilling Programme

SOCSO Course Category:
Manufacturing

SOCSO Course Code:
HIT3041

Course Title:
Medtech Upskilling Course

Duration:
7 Days

Target Group:
For retrenched workers to learn new skills and enable them to work again.

Target Industry:
Medical Device Manufacturing Industry

Certification:

  • Certificate of Competency in Medtech Upskilling Course will be awarded to participants upon the passing of final assessment (60 marks and above)
  • Certificate of Attendance in Medtech Upskilling Course will be awarded to the participants if they failed the final assessment (60 marks and below)
  • Certification body: Association of Malaysian Medical Industries (AMMI)

Course Objectives:
The Medtech Upskilling Course aims to develop, enhance and certify skills and knowledge of unemployed Malaysian on the requirements of the medical industry. This includes the understanding of the medical industry and the significance of quality and regulatory compliance; key medical device regulatory systems; importance of Good Manufacturing Practice, Good Documentation Practice; ISO13485 standard and implications; manufacturing essential practices and implications.

Methods/ Methodology Course :
Lecture
Case Studies
Pre-Test and Post-Test

Course Content:
• Overview of Medical Device Classification, Labelling and CE Marking
• ISO 13485 Quality Management System and 21 CFR Part 820
• EN ISO 14971 Risk Management
• Process Validation for Medical Devices

Learning Outcomes:
Upon successful completion of the training, participants will be able to:
• Understand the medical industry and its practices, regulations and compliance requirements
• Knowledge on the Medical Device Regulatory System
• Knowledge on the Medical Device Classification and the differences in requirements and practices
• Learn and understand the importance of Good Manufacturing Practice and the importance of adherence for quality and patient safety
• Learn and understand the importance of Good Documentation Practice for traceability and impact on quality and patient safety
• Knowledge on bio burden and microbiology control; effects of bio burden and microbiology control on product quality and patient safety; outcomes and impact of improper control
• Understand the Production Process change controls, validation, qualification and the significance of ability to maintain the changed processes
• Learn the importance of labelling requirements and the consequences of non-adherence and wrong labelling to product and patient safety
• Learn about audits and its requirements, guidelines and preparedness
• Equipped with patient safety, quality and compliant mindset as the basis for a competent medtech employee