| No. |
Training Provider |
Training Topic |
Contact Person |
Contact Details |
| 1. |
Association of Malaysian Medical Industries (AMMI) |
Medtech Professional Certificate in Manufacturing Excellence |
Mr CS Ching |
learning@ammi.com.my |
| 2. |
Association of Malaysian Medical Industries (AMMI) |
Medtech Professional Certificate in Quality Assurance |
Mr CS Ching |
learning@ammi.com.my |
| 3. |
Association of Malaysian Medical Industries (AMMI) |
Medtech Professional Certificate in Regulatory Affairs |
Mr CS Ching |
learning@ammi.com.my |
| 4. |
Association of Malaysian Medical Industries (AMMI) |
Medtech Professional Certificate in Medical Device Industry (Fundamental) |
Mr CS Ching |
learning@ammi.com.my |
| 5. |
Association of Malaysian Medical Industries (AMMI) |
Medtech Professional Certificate in Production (Fundamental) |
Mr CS Ching |
learning@ammi.com.my |
| 6. |
Association of Malaysian Medical Industries (AMMI) |
21 CFR Part 820 / Quality Management System Regulation (QMSR) |
Mr CS Ching |
learning@ammi.com.my |
| 7. |
Association of Malaysian Medical Industries (AMMI) |
US FDA Quality Management System Regulation (QMSR) |
Mr CS Ching |
learning@ammi.com.my |
| 8. |
Association of Malaysian Medical Industries (AMMI) |
Medical Device Regulation (EU) 2017/745 |
Mr CS Ching |
learning@ammi.com.my |
| 9. |
Association of Malaysian Medical Industries (AMMI) |
EN ISO 14971 Risk Management |
Mr CS Ching |
learning@ammi.com.my |
| 10. |
Association of Malaysian Medical Industries (AMMI) |
NCR / CAPA / Complaint Handling |
Mr CS Ching |
learning@ammi.com.my |
| 11. |
Association of Malaysian Medical Industries (AMMI) |
Effective Root Cause Analysis |
Mr CS Ching |
learning@ammi.com.my |
| 12. |
Association of Malaysian Medical Industries (AMMI) |
Acceptance Sampling Method |
Mr CS Ching |
learning@ammi.com.my |
| 13. |
Association of Malaysian Medical Industries (AMMI) |
Lean Manufacturing |
Mr CS Ching |
learning@ammi.com.my |
| 14. |
Association of Malaysian Medical Industries (AMMI) |
Process Mapping |
Mr CS Ching |
learning@ammi.com.my |
| 15. |
Association of Malaysian Medical Industries (AMMI) |
Process Validation |
Mr CS Ching |
learning@ammi.com.my |
| 16. |
Association of Malaysian Medical Industries (AMMI) |
Hypothesis Testing |
Mr CS Ching |
learning@ammi.com.my |
| 17. |
Association of Malaysian Medical Industries (AMMI) |
Statistical Process Control and Capability Analysis |
Mr CS Ching |
learning@ammi.com.my |
| 18. |
Association of Malaysian Medical Industries (AMMI) |
Measurement System Analysis |
Mr CS Ching |
learning@ammi.com.my |
| 19. |
Association of Malaysian Medical Industries (AMMI) |
Design of Experiments |
Mr CS Ching |
learning@ammi.com.my |
| 20. |
Association of Malaysian Medical Industries (AMMI) |
Fundamentals of Global Medical Device Regulatory System (major markets including ASEAN) |
Mr CS Ching |
learning@ammi.com.my |
| 21. |
Association of Malaysian Medical Industries (AMMI) |
Role of the Regulatory Professional & Medical Device Regulatory Process Planning |
Mr CS Ching |
learning@ammi.com.my |
| 22. |
Association of Malaysian Medical Industries (AMMI) |
Malaysia Medical Device Regulations |
Mr CS Ching |
learning@ammi.com.my |
| 23. |
Association of Malaysian Medical Industries (AMMI) |
US FDA Pre-Market Requirements |
Mr CS Ching |
learning@ammi.com.my |
| 24. |
Association of Malaysian Medical Industries (AMMI) |
Change Control and Product Safety |
Mr CS Ching |
learning@ammi.com.my |
| 25. |
Association of Malaysian Medical Industries (AMMI) |
ISO 13485:2016 Quality Management System |
Mr CS Ching |
learning@ammi.com.my |
| 26. |
Association of Malaysian Medical Industries (AMMI) |
ISO 13485:2016 Internal Audit |
Mr CS Ching |
learning@ammi.com.my |
| 27. |
Association of Malaysian Medical Industries (AMMI) |
Medical Device Single Audit Programme (MDSAP) |
Mr CS Ching |
learning@ammi.com.my |
| 28. |
Association of Malaysian Medical Industries (AMMI) |
Medical Device Identification, Classification and Labelling |
Mr CS Ching |
learning@ammi.com.my |
| 29. |
Association of Malaysian Medical Industries (AMMI) |
Software Validation Requirements and Excel Spreadsheet Validation |
Mr CS Ching |
learning@ammi.com.my |
| 30. |
Association of Malaysian Medical Industries (AMMI) |
Test Method Validation |
Mr CS Ching |
learning@ammi.com.my |
| 31. |
Association of Malaysian Medical Industries (AMMI) |
Design Control |
Mr CS Ching |
learning@ammi.com.my |
| 32. |
Association of Malaysian Medical Industries (AMMI) |
Change Control |
Mr CS Ching |
learning@ammi.com.my |
| 33. |
Association of Malaysian Medical Industries (AMMI) |
Medical Device Usability (Human Factor Engineering) |
Mr CS Ching |
learning@ammi.com.my |
| 34. |
Association of Malaysian Medical Industries (AMMI) |
Ethylene Oxide Sterilization |
Mr CS Ching |
learning@ammi.com.my |
| 35. |
Association of Malaysian Medical Industries (AMMI) |
Gamma Radiation Sterilization |
Mr CS Ching |
learning@ammi.com.my |
| 36. |
Association of Malaysian Medical Industries (AMMI) |
Bioburden Test and Test of Sterility |
Mr CS Ching |
learning@ammi.com.my |
| 37. |
Association of Malaysian Medical Industries (AMMI) |
Cleanroom and Associated Control Environments |
Mr CS Ching |
learning@ammi.com.my |
| 38. |
Association of Malaysian Medical Industries (AMMI) |
Malaysia Good Distribution Practice for Medical Device (GDPMD) |
Mr CS Ching |
learning@ammi.com.my |
| 39. |
Association of Malaysian Medical Industries (AMMI) |
GDPMD Internal Audit |
Mr CS Ching |
learning@ammi.com.my |
| 40. |
Association of Malaysian Medical Industries (AMMI) |
Good Documentation Practices |
Mr CS Ching |
learning@ammi.com.my |
| 41. |
Association of Malaysian Medical Industries (AMMI) |
Failure Modes and Effects Analysis (FMEA) |
Mr CS Ching |
learning@ammi.com.my |
| 42. |
Association of Malaysian Medical Industries (AMMI) |
Supply Chain Management (Medical Device Industry) |
Mr CS Ching |
learning@ammi.com.my |
| 43. |
Association of Malaysian Medical Industries (AMMI) |
IEC 62304 Sodtware of Medical Device |
Mr CS Ching |
learning@ammi.com.my |
| 44. |
Association of Malaysian Medical Industries (AMMI) |
6S for Visual Workplace: Foundation for Lean Manufacturing & Workplace Organization for Medical Device Manufacturers |
Mr CS Ching |
learning@ammi.com.my |
| 45. |
Association of Malaysian Medical Industries (AMMI) |
Cost of Quality |
Mr CS Ching |
learning@ammi.com.my |
| 46. |
Center for Innovation in Medical Engineering |
Development of Good Distribution Practice for Medical Devices (GDPMD) |
Dr Nurul Fauzani |
cime@um.edu.my |
| 47. |
Center for Innovation in Medical Engineering |
ISO 13485 – Medical Devices Quality Management Systems |
Dr Nurul Fauzani |
cime@um.edu.my |
| 48. |
Center for Innovation in Medical Engineering |
ISO 14971 – Medical Devices Application of Risk Management to Medical Devices |
Dr Nurul Fauzani |
cime@um.edu.my |
| 49. |
Center for Innovation in Medical Engineering |
Medical Device Disposal MS 2650:2015 |
Dr Nurul Fauzani |
cime@um.edu.my |
| 50. |
Center for Innovation in Medical Engineering |
Medical Device Act 2012 (Act 737) |
Dr Nurul Fauzani |
cime@um.edu.my |
| 51. |
Center for Innovation in Medical Engineering |
Requirements Atomic Energy Licensing Act 1984 (Act 304) |
Dr Nurul Fauzani |
cime@um.edu.my |
| 52. |
Center for Innovation in Medical Engineering |
MS 2058 – Code of Practice for Good Engineering Maintenance Management of Active Medical Devices |
Dr Nurul Fauzani |
cime@um.edu.my |
| 53. |
Center for Innovation in Medical Engineering |
CCM 4 – Introduction to Healthcare, Medical Device Safety and Risk Management |
Dr Nurul Fauzani |
cime@um.edu.my |
| 54. |
Center for Innovation in Medical Engineering |
IEC 62353 Medical Electrical Equipment – recurrent test and test after repair of ME equipment |
Dr Nurul Fauzani |
cime@um.edu.my |
| 55. |
Center for Innovation in Medical Engineering |
MS 2739 – Code of Practice – Requirements for Installation, Testing and Comissioning and Acceptance of Medical Device |
Dr Nurul Fauzani |
cime@um.edu.my |
| 56. |
Center for Innovation in Medical Engineering |
Medical Device Risk Classification & Grouping |
Dr Nurul Fauzani |
cime@um.edu.my |
| 57. |
Center for Innovation in Medical Engineering |
Duties & Obligations of Establishment: Post-Market Activities |
Dr Nurul Fauzani |
cime@um.edu.my |
| 58. |
Center for Innovation in Medical Engineering |
Registration of Conformity Assessment Body (CAB) |
Dr Nurul Fauzani |
cime@um.edu.my |
| 59. |
Center for Innovation in Medical Engineering |
IEC Standards Drive Sustainability of Healthcare Industries |
Dr Nurul Fauzani |
cime@um.edu.my |
| 60. |
Center for Innovation in Medical Engineering |
Non-ionizing Radiation Safety and Application on Laser |
Dr Nurul Fauzani |
cime@um.edu.my |
| 61. |
Center for Innovation in Medical Engineering |
ICT in Healthcare |
Dr Nurul Fauzani |
cime@um.edu.my |
| 62. |
Center for Innovation in Medical Engineering |
Code of Practice for Good Engineering Maintenance |
Dr Nurul Fauzani |
cime@um.edu.my |
| 63. |
Center for Innovation in Medical Engineering |
Management of Active Medical Devices |
Dr Nurul Fauzani |
cime@um.edu.my |
| 64. |
Smart Management Consultancy & Resources Sdn Bhd |
Mastering Medical Device Regulation: A Course on Process Validation and Compliance |
Dr. Kevnsrenath Gingaiah |
ceo@smcresources.com / 0124041085 |
| 65. |
Smart Management Consultancy & Resources Sdn Bhd |
Advanced Sterilization Techniques and Protocols for Medical Devices |
Dr. Kevnsrenath Gingaiah |
ceo@smcresources.com / 0124041085 |
| 66. |
Smart Management Consultancy & Resources Sdn Bhd |
Implementing Medical Device Cybersecurity Best Practices |
Dr. Kevnsrenath Gingaiah |
ceo@smcresources.com / 0124041085 |
| 67. |
Smart Management Consultancy & Resources Sdn Bhd |
Risk Management for Medical Devices: ISO 14971 Application |
Dr. Kevnsrenath Gingaiah |
ceo@smcresources.com / 0124041085 |
| 68. |
Smart Management Consultancy & Resources Sdn Bhd |
Biocompatibility Testing in Medical Device Development |
Dr. Kevnsrenath Gingaiah |
ceo@smcresources.com / 0124041085 |
| 69. |
Smart Management Consultancy & Resources Sdn Bhd |
Regulatory Pathways for Medical Device Approval in ASEAN Markets |
Dr. Kevnsrenath Gingaiah |
ceo@smcresources.com / 0124041085 |
| 70. |
Smart Management Consultancy & Resources Sdn Bhd |
Effective Process Validation in Quality Management Systems |
Dr. Kevnsrenath Gingaiah |
ceo@smcresources.com / 0124041085 |
| 71. |
SaniChem Resources Sdn Bhd |
Fundamentals of Bioburden Testing: Principles and Relevance in the Medical Device Industry |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 72. |
SaniChem Resources Sdn Bhd |
Practical Skills and Analysis in Bioburden Testing |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 73. |
SaniChem Resources Sdn Bhd |
Advanced Bioburden Testing Techniques and Problem-solving |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 74. |
SaniChem Resources Sdn Bhd |
Endotoxin Testing Essentials |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 75. |
SaniChem Resources Sdn Bhd |
Fundamentals of Sterility Testing: Principles and Importance |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 76. |
SaniChem Resources Sdn Bhd |
Fundamentals of EO Residual Testing: Principles and Importance |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 77. |
SaniChem Resources Sdn Bhd |
Training on ISO 13485:2016 Medical Device Quality Management System (MDQMS) Awareness |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 78. |
SaniChem Resources Sdn Bhd |
Sterilization: Awareness Training in ISO 11137 |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 79. |
SaniChem Resources Sdn Bhd |
Sterilization: Awareness Training in ISO11607-1 and ISO 11607-2 |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 80. |
SaniChem Resources Sdn Bhd |
Ethylene Oxide Sterilization: Awareness Training in ISO 11135:2014 |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 81. |
SaniChem Resources Sdn Bhd |
Awareness Training in ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 82. |
SaniChem Resources Sdn Bhd |
Introduction to ISO 17025 |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 83. |
SaniChem Resources Sdn Bhd |
Moist Heat Sterilization: Awareness Training in ISO 17665-1:2006 |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 84. |
SaniChem Resources Sdn Bhd |
Mastering Endotoxin Testing (Kinetic Turbidimetric) Techniques |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 85. |
SaniChem Resources Sdn Bhd |
Advanced Endotoxin Testing (Kinetic Turbidimetric) and Regulatory Compliance |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 86. |
SaniChem Resources Sdn Bhd |
Practical Skills and Analysis in Sterility Testing |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 87. |
SaniChem Resources Sdn Bhd |
Advanced Sterility Testing and Regulatory Compliance |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 88. |
SaniChem Resources Sdn Bhd |
Sterilization: Awareness Training in ISO 11137 (4 days) |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 89. |
SaniChem Resources Sdn Bhd |
Validation and Verification Test Method Training |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 90. |
SaniChem Resources Sdn Bhd |
Practical and Analysis in Ethylene Oxide Residual Testing |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 91. |
SaniChem Resources Sdn Bhd |
Control Room: Evaluate possible sources of microorganisms and potential to impact product bioburden |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 92. |
SaniChem Resources Sdn Bhd |
Extraction for Ethylene Oxide Residual Testing |
Mohd Naim Abdul Halim |
info@sanichem.com.my |
| 93. |
DreamCatcher |
Key Aspects Of ISO 10993-1 Biological Evaluation and Biocompatibility Testing For Medical Devices |
Dr. Shangeetha Ganesan |
enquiry@dreamcatcher.asia |
| 94. |
DreamCatcher |
Understanding of Biological Evaluations for Medical Devices |
Dr. Shangeetha Ganesan |
enquiry@dreamcatcher.asia |
| 95. |
DreamCatcher |
Good Manufacturing Practice (GMP) Updates Affecting Sterile Production |
Dr. Shangeetha Ganesan |
enquiry@dreamcatcher.asia |
| 96. |
DreamCatcher |
Quality Risk Management Workshop For Life Science Industry |
Dr. Shangeetha Ganesan |
enquiry@dreamcatcher.asia |
| 97. |
DreamCatcher |
Workshop On Successful Implementation Of Risk Management For Medical Devices : EN ISO 14971:2019 |
Dr. Shangeetha Ganesan |
enquiry@dreamcatcher.asia |
| 98. |
DreamCatcher |
Avoiding Common Weaknesses In Risk Management For Medical Devices : EN ISO 14971:2019 |
Dr. Shangeetha Ganesan |
enquiry@dreamcatcher.asia |
| 99. |
DreamCatcher |
Sterilization Validation |
Dr. Shangeetha Ganesan |
enquiry@dreamcatcher.asia |
| 100. |
DreamCatcher |
Essentials of Medical Devices Manufacturing Process Validation |
Dr. Shangeetha Ganesan |
enquiry@dreamcatcher.asia |
| 101. |
DreamCatcher |
Failure Analysis of Materials Related to Medical Products Using FTIR |
Dr. Shangeetha Ganesan |
enquiry@dreamcatcher.asia |
| 102. |
DreamCatcher |
Tools for Failure Analysis for Medical and Related Products using FTIR, SEM-EDS, XPS ad TGA |
Dr. Shangeetha Ganesan |
enquiry@dreamcatcher.asia |
| 103. |
DreamCatcher |
Application of FTIR for materials analysis related to medical products |
Dr. Shangeetha Ganesan |
enquiry@dreamcatcher.asia |
| 104. |
DreamCatcher |
ISO 11607-1 & ISO 11607-2:2019: Packaging for Terminally Sterilized Medical Gloves – Design, Testing & Process Validation |
Dr. Shangeetha Ganesan |
enquiry@dreamcatcher.asia |
| 105. |
DreamCatcher |
Sterilization Of Medical Devices Using Ethylene Oxide and Gamma Irradiation |
Dr. Shangeetha Ganesan |
enquiry@dreamcatcher.asia |
| 106. |
DreamCatcher |
Advance Sterilization & The Aseptic Presentation of Medical Devices |
Dr. Shangeetha Ganesan |
enquiry@dreamcatcher.asia |
| 107. |
DreamCatcher |
Understanding of Different Sterilization Technologies, Their Use and Qualifications in Life Science Industry |
Dr. Shangeetha Ganesan |
enquiry@dreamcatcher.asia |
| 108. |
DreamCatcher |
Sterilization Validation |
Dr. Shangeetha Ganesan |
enquiry@dreamcatcher.asia |
| 109. |
DreamCatcher |
How to improve ESG scores in the glove industry? |
Dr. Shangeetha Ganesan |
enquiry@dreamcatcher.asia |
| 110. |
DreamCatcher |
Introduction to Additive Manufacturing (AM) with Practical Applications |
En. Azhar Amin |
enquiry@dreamcatcher.asia |