Medtech Foundation Programme

SOCSO Course Category:
Manufacturing

SOCSO Course Code:
HIT 3042

Course Title:
Medtech Foundation Course

Duration:
5 Days

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

Target Industry:
Medical Device Manufacturing Industry

Certification:

  • Certificate of Competency in Medtech Foundation Course will be awarded to participants upon the passing of final assessment (60 marks and above)
  • Certificate of Attendance in Medtech Foundation 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 Foundation Course aims to accelerate skills of new hires to meet the needs of companies that require professionals with knowledgeable about medical device industry. Participants will be exposed to the regulated medical device industry and the quality system that governs the industry.

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

Course Content:
• Introduction to Medical Device Industry and Quality Mind-set
• Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP)
• Importance of Safety in Medical Device Manufacturing Environment
• Cleanroom Contamination Control & Personnel Hygiene Control
• 5S in Medical Device Industry

Learning Outcomes:
Upon successful completion of the training, participants will be able to:
• Have an general overview on Medical Device Industry and the quality systems that governs the industry
• Understand basics of GMP and GDP
• Understand essential principles of safety in the manufacturing environment
• Understand fundamental information for cleanroom operations
• Understand sources of contamination and safety practices in cleanroom
• Have a practical understanding of the 5S principles and how it can be applied to the organisation