SOCSO Course Category:
Manufacturing
SOCSO Course Code:
HIT3043
Course Title:
Introduction to Medical Device Manufacturing
Duration:
3 Days
Target Industry:
Medical Device Manufacturing Industry
Certification:
Certificate of Attendance
Certification body:
Association of Malaysian Medical Industries (AMMI)
Course Objectives:
Introduction to Medical Device Manufacturing aims to upskill new hires on the requirements of the medical device manufacturing industry. This includes the understanding of the medical device industry and the significance of quality and regulatory compliance; importance of Good Manufacturing Practice, Good Documentation Practice.
Methods/ Course Methodology:
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
Learning Outcomes:
Upon successful completion of the training, participants will be able to:
• Have a general overview of Medical Device Industry and the quality systems that govern the industry
• Understand basics of GMP and GDP
• Understand safety practices in the manufacturing environment