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13 -14 April 2026: Medical Device Manufacturing Process Validation

Medical Device Manufacturing Process Validation

DATE:  13 – 14 April 2026

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang

DURATION: 2 full-day course

COURSE OBJECTIVES
This course provides quality systems professionals, manufacturing engineers, and process
development engineers with the knowledge and skills needed to comply with the process validation
requirements of the US FDA Quality Management System Regulation, ISO 13485 and the GHTF
Validation guidance N99-10 while offering information on how to implement an effective validation
program.

COURSE OUTLINE
1. Validation – ISO and regulatory requirements
2. Validation master plan
3. Risk assessment in process validation
4. Statistical tools and techniques
5. Validation system
6. Process validation
7. Software validation
8. Equipment / Software – DQ/IQ/OQ and PQ
9. Change control
10. Validation – Good Documentation Practices

COURSE FEES (8% SST included)

Early Bird Price (until 23 March 2026)
AMMI Member: RM 1,998.00
Public: RM 2,214.00

Normal Price (from 24 March 2026 onwards)
AMMI Member: RM 2,214.00
Public: RM 2,430.00

Bonus deal for group registration
For the 6th pax to 9th pax: 30% discount
For the 10th pax & above: 75% discount

 

CONTACT
For enquiries, please email to Medsociate Sdn Bhd
Authorised training provider of AMMI
Email: learning@ammi.com.my / admin@medsociate.com
Tel: +6012 539 4194

DOWNLOAD BROCHURE
REGISTER HERE
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1 October 2025: AMMI Gala Dinner

AMMI Gala Dinner 2025 was held on 1 October at G Hotel Gurney, Penang, welcoming 380 attendees, including AMMI members and key stakeholders from the medical device industry, for an evening of camaraderie, networking, and celebration. The highlight of the night was the presence of the Chief Minister of Penang as Guest of Honour, underscoring the state’s strong commitment to supporting the growth and innovation of the medical device sector.

AMMI Gala Dinner 2025 (Collection 1)

AMMI Dinner_561
AMMI Summit_785
AMMI Dinner_583
AMMI Dinner_579
AMMI Dinner_575
AMMI Summit_780
Photocorner_40
Photocorner_42
AMMI Summit_759
AMMI Dinner_585
AMMI Dinner_587
AMMI Dinner_534
AMMI Dinner_566
AMMI Dinner_540
AMMI Dinner_570
AMMI Dinner_558
AMMI Dinner_542
AMMI Dinner_508
AMMI Dinner_546
AMMI Dinner_513
AMMI Dinner_520
AMMI Dinner_493
AMMI Dinner_500
AMMI Dinner_481
AMMI Dinner_445
AMMI Dinner_503
AMMI Dinner_401
AMMI Dinner_438
AMMI Dinner_484
AMMI Dinner_496
AMMI Dinner_452
AMMI Dinner_475
AMMI Dinner_407
AMMI Dinner_425
AMMI Dinner_478
AMMI Dinner_396
AMMI Dinner_389
AMMI Dinner_430
AMMI Dinner_416
AMMI Dinner_474
AMMI Dinner_415
AMMI Dinner_428
AMMI Dinner_409
AMMI Dinner_423
AMMI Dinner_411
AMMI Dinner_385
AMMI Dinner_403
AMMI Dinner_352
AMMI Dinner_383
AMMI Dinner_339
AMMI Dinner_212
AMMI Dinner_335
AMMI Dinner_337
AMMI Dinner_320
AMMI Dinner_181
AMMI Dinner_234
AMMI Dinner_201
AMMI Dinner_249
AMMI Dinner_242
AMMI Dinner_372
AMMI Dinner_200
AMMI Dinner_374
AMMI Dinner_326
AMMI Dinner_251
AMMI Dinner_214
AMMI Dinner_203
AMMI Dinner_238
AMMI Dinner_264
AMMI Dinner_219
AMMI Dinner_222
AMMI Dinner_282
AMMI Dinner_329
AMMI Dinner_216
AMMI Dinner_244
AMMI Dinner_324
AMMI Dinner_272
AMMI Dinner_206
AMMI Dinner_196
AMMI Dinner_194
AMMI Dinner_164
AMMI Dinner_65
AMMI Dinner_47
AMMI Dinner_96
AMMI Dinner_176
AMMI Dinner_149
AMMI Dinner_109
AMMI Dinner_168
AMMI Dinner_105
AMMI Dinner_72
AMMI Dinner_146
AMMI Dinner_136
AMMI Dinner_185
AMMI Dinner_119
AMMI Dinner_36
AMMI Dinner_150
AMMI Dinner_152
AMMI Dinner_38
AMMI Dinner_98
AMMI Dinner_99
AMMI Dinner_130
AMMI Dinner_103
AMMI Dinner_39
AMMI Dinner_63
AMMI Dinner_44
AMMI Dinner_69
AMMI Dinner_53
AMMI Dinner_20
AMMI Dinner_31
AMMI Dinner_22
AMMI Dinner_57
AMMI Dinner_561 AMMI Summit_785 AMMI Dinner_583 AMMI Dinner_579 AMMI Dinner_575 AMMI Summit_780 Photocorner_40 Photocorner_42 AMMI Summit_759 AMMI Dinner_585 AMMI Dinner_587 AMMI Dinner_534 AMMI Dinner_566 AMMI Dinner_540 AMMI Dinner_570 AMMI Dinner_558 AMMI Dinner_542 AMMI Dinner_508 AMMI Dinner_546 AMMI Dinner_513 AMMI Dinner_520 AMMI Dinner_493 AMMI Dinner_500 AMMI Dinner_481 AMMI Dinner_445 AMMI Dinner_503 AMMI Dinner_401 AMMI Dinner_438 AMMI Dinner_484 AMMI Dinner_496 AMMI Dinner_452 AMMI Dinner_475 AMMI Dinner_407 AMMI Dinner_425 AMMI Dinner_478 AMMI Dinner_396 AMMI Dinner_389 AMMI Dinner_430 AMMI Dinner_416 AMMI Dinner_474 AMMI Dinner_415 AMMI Dinner_428 AMMI Dinner_409 AMMI Dinner_423 AMMI Dinner_411 AMMI Dinner_385 AMMI Dinner_403 AMMI Dinner_352 AMMI Dinner_383 AMMI Dinner_339 AMMI Dinner_212 AMMI Dinner_335 AMMI Dinner_337 AMMI Dinner_320 AMMI Dinner_181 AMMI Dinner_234 AMMI Dinner_201 AMMI Dinner_249 AMMI Dinner_242 AMMI Dinner_372 AMMI Dinner_200 AMMI Dinner_374 AMMI Dinner_326 AMMI Dinner_251 AMMI Dinner_214 AMMI Dinner_203 AMMI Dinner_238 AMMI Dinner_264 AMMI Dinner_219 AMMI Dinner_222 AMMI Dinner_282 AMMI Dinner_329 AMMI Dinner_216 AMMI Dinner_244 AMMI Dinner_324 AMMI Dinner_272 AMMI Dinner_206 AMMI Dinner_196 AMMI Dinner_194 AMMI Dinner_164 AMMI Dinner_65 AMMI Dinner_47 AMMI Dinner_96 AMMI Dinner_176 AMMI Dinner_149 AMMI Dinner_109 AMMI Dinner_168 AMMI Dinner_105 AMMI Dinner_72 AMMI Dinner_146 AMMI Dinner_136 AMMI Dinner_185 AMMI Dinner_119 AMMI Dinner_36 AMMI Dinner_150 AMMI Dinner_152 AMMI Dinner_38 AMMI Dinner_98 AMMI Dinner_99 AMMI Dinner_130 AMMI Dinner_103 AMMI Dinner_39 AMMI Dinner_63 AMMI Dinner_44 AMMI Dinner_69 AMMI Dinner_53 AMMI Dinner_20 AMMI Dinner_31 AMMI Dinner_22 AMMI Dinner_57
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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 LogoCompany NameLocationWebsiteResume Drop-Off
Abbott MalaysiaBayan Lepas, Penangwww.my.abbottCLICK HERE
Ambu Sdn BhdBayan Lepas , Penangwww.ambu.comCLICK HERE
Amcor Flexibles Asia Pacific (Bemis Asia Pacific Sdn Bhd)Subang Jaya, Selangorwww.amcor.comCLICK HERE
B Braun Medical Industries Sdn BhdBayan Lepas, Penang, www.bbraun.comCLICK HERE
Boston Scientific Medical Device (Malaysia) Sdn BhdBatu Kawan, Penangwww.bostonscientific.comCLICK HERE
Becton-Dickinson (BD)Kulim, Kedah www.bd.com/en-myCLICK HERE
Ciba Vision Johor Sdn BhdGelang Patah, Johorwww.alcon.com

CLICK HERE
Diptech Industries Sdn. Bhd.Sungai Petani, Kedahwww.diptech.com.myCLICK HERE
Fresenius Medical Care Production Sdn BhdNegeri Sembilanwww.freseniusmedicalcare.myCLICK HERE
KLS Martin Malaysia Sdn BhdSimpang Ampat, Penangwww.klsmartin.comCLICK HERE
Tecan CDMO Solutions PN Sdn BhdSimpang Ampat, Penangwww.paramit.comCLICK HERE
Symmetry Medical Malaysia Sdn BhdBayan Lepas, Penang www.tecomet.comCLICK HERE
Teleflex Medical Sdn. Bhd.Kamunting, Perakwww.teleflexmedical.comCLICK HERE
UWHM Sdn BhdBatu Kawan, Penangwww.uw-healthcare.comCLICK HERE
Tako Technology Sdn BhdBeranang, Selangorwww.tako.com.myCLICK HERE
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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

  1. Background
  2. Quality Management System (prerequisites and what to be considered)
  3. Quality System Regulation (guidance about Sub-Parts A to O)
  4. Resources and Links
  5. Implementation of Quality System Regulation
  6. Maintaining compliance to 21 CFR Part 820
  7. Quality System Inspection Technique (QSIT)
  8. 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

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