You are invited to submit your 2022 training wishlist and we will turn the most requested courses into public training classes for you!
2022 AMMI Public Training Wish List
AMMI Medical Device Industry Recruitment
Interested to apply for INTERNSHIPS and JOBS at AMMI member companies? Click and submit your resume to the companies listed below. For your information, only shortlisted candidates will be contacted by the respective companies.
| Company Logo | Company Name | Location | Website | Resume Drop-Off |
|---|---|---|---|---|
 | Abbott Malaysia | Bayan Lepas, Penang | www.my.abbott | CLICK HERE |
 | Ambu Sdn Bhd | Bayan Lepas , Penang | www.ambu.com | CLICK HERE |
 | Amcor Flexibles Asia Pacific (Bemis Asia Pacific Sdn Bhd) | Subang Jaya, Selangor | www.amcor.com | CLICK HERE |
 | B Braun Medical Industries Sdn Bhd | Bayan Lepas, Penang, | www.bbraun.com | CLICK HERE |
 | Boston Scientific Medical Device (Malaysia) Sdn Bhd | Batu Kawan, Penang | www.bostonscientific.com | CLICK HERE |
 | Becton-Dickinson (BD) | Kulim, Kedah | www.bd.com/en-my | CLICK HERE |
 | Ciba Vision Johor Sdn Bhd | Gelang Patah, Johor | www.alcon.com | CLICK HERE |
 | Diptech Industries Sdn. Bhd. | Sungai Petani, Kedah | www.diptech.com.my | CLICK HERE |
 | Fresenius Medical Care Production Sdn Bhd | Negeri Sembilan | www.freseniusmedicalcare.my | CLICK HERE |
 | KLS Martin Malaysia Sdn Bhd | Simpang Ampat, Penang | www.klsmartin.com | CLICK HERE |
 | Tecan CDMO Solutions PN Sdn Bhd | Simpang Ampat, Penang | www.paramit.com | CLICK HERE |
 | Symmetry Medical Malaysia Sdn Bhd | Bayan Lepas, Penang | www.tecomet.com | CLICK HERE |
 | Teleflex Medical Sdn. Bhd. | Kamunting, Perak | www.teleflexmedical.com | CLICK HERE |
 | UWHM Sdn Bhd | Batu Kawan, Penang | www.uw-healthcare.com | CLICK HERE |
 | Tako Technology Sdn Bhd | Beranang, Selangor | www.tako.com.my | CLICK HERE |
21 CFR Part 820 Quality System Regulation and FDA CGMP Requirements for Medical Device
Course Title: 21 CFR Part 820 Quality System Regulation and FDA CGMP Requirements for Medical Devices
SOCSO Course Category: Manufacturing
SOCSO Course Code: HIT3054
INTRODUCTION
This course introduces the concepts needed to understand, develop, implement and run a quality system as outlined in the US FDA 21 CFR 820 Code of Federal Regulations. It provides understanding the legal requirements and regulatory expectations relating to cGMP Quality System Regulation (QSR), as well as the cost of non-compliance.
COURSE OUTLINE
- Background
- Quality Management System (prerequisites and what to be considered)
- Quality System Regulation (guidance about Sub-Parts A to O)
- Resources and Links
- Implementation of Quality System Regulation
- Maintaining compliance to 21 CFR Part 820
- Quality System Inspection Technique (QSIT)
- The FDA Inspection Process / How to get ready for FDA Plant
Inspections
TARGET AUDIENCE
Anyone involved in defining, planning, implementing or running a 21 CFR 820 compliance GMP Quality Management System, management representatives, implementation team members, management or Quality personnel working in the medical device industry. Quality Assurance Manager/personnel expecting and/or preparing for a FDA Inspection.
PRE-REQUISITE
Knowledge about quality management system for Medical Device Industry (ISO 13485:2016) would be beneficial.
DURATION
Two (2) full days
AMMI Medtech Training Track Record
Talent Development at AMMI
Talent Development is a key pillar at AMMI. With this pillar, AMMI aims to:
- Support continuous development of a skilled and adaptable workforce;
- Increase awareness of opportunities in the medical technology sector
- Facilitate the transfer and sharing of knowledge within our industr
Key initiatives to achieve its talent development objectives are through implementation of the following:
- Medtech training
- Global expert knowledge sharing
- Collaboration with higher education institutes
- HR leaders’ roundtable
AMMI trains around 500-600 participants a year, through its public training courses, medtech programmes as well as Global Expert Sharing Session. Below are some of the graduation photos.
Medtech Foundation Course
SOCSO Course Category:
Manufacturing
SOCSO Course Code:
HIT 3042
Course Title:
Medtech Foundation Course
Duration:
5 Days
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