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22-23 May 2023: Medical Device Manufacturing Process Validation

Medical Device Manufacturing Process Validation

22 – 23 May 2023

2 full days

Hybrid – Select from Classroom Training (Hotel)  or Online Training (Zoom)

8.30am – 5.30pm

Eastin Hotel Penang

Online Training will be via Zoom.


The global medical device market is governed by various quality system requirements and regulations of different countries. Medical device manufacturers need to perform process validation in order to comply with regulatory requirements and ensure business success



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



  1. Regulatory/QMS Compliance

1.1. QSR-21 CFR Part 820/ 21 CFR Part 11

1.2. ISO 13485:2016, GHTF/SG3/N99-10:2004 (Edition 2)


  1. A Brief Introduction to Validation System

2.1. Process Validation/Software Validation System/Analytical Method Validation System

2.2  Cleaning Validation System/Packaging Validation/Sterilization Validation


  1. Introduction to Process Validation

3.1. Overall Validation Program Description

3.2. Validation Definition

3.3 Process Validation Decision Tree

3.4. Types of Validation

3.4.1. Prospective Validation/ Concurrent Validation

3.4.2 Retrospective Validation/Revalidation


  1. Validation Master Plan

4.1. Life Cycle Approach in Process Validation

4.2. Risk Assessment in Process Validation


  1. Elements of Process Validation System

5.1. Installation Qualification (IQ)/Operational Qualification (OQ)/Performance

Qualification (PQ)

5.2. Maintaining State of Validation

5.3. Deviation in Process Validation

5.4. Change Control in Process Validation


  1. Statistical Tools & Techniques

6.1. Acceptance Sampling Plan

6.2. Measurement System Analysis

6.3. The 7 Basic QC Tools

6.4. Process Capability Analysis

6.5. Statistical Method and Data Analysis

  1. Validation- Benefits and Good Documentation Practice

7.1. Good Validation Documentation Practice

7.2. Benefits of Process Validation



Regulatory/quality systems professionals, manufacturing engineers, and process development engineers

This is a hybrid training course – you may select Classroom Training (Hotel) or Online Training (Zoom). The organiser reserves the right to switch to full online training by giving due notice to the registered participants.

Sign up for more than 6 pax, and enjoy special Group Registration Fee and Bonus Deal.

Course Fees – for 2 days Classroom Training (Hotel)
RM (inc 6% SST)
Online Training (Zoom)
RM (inc 6% SST)
Early Bird Course Fees (Registration by 1 May 2023)
AMMI Member  1,590.00 1,272.00
Non Member    1,802.00  1,484.00
Normal Course Fees  (Registration from 2 May 2023 onwards)
AMMI Member 1,802.00 1,484.00
Non Member   2,014.00 1,696.00
Package Deals
Group Registration > 6 pax                 1,484.00  1,166.00
Bonus Deal (10th – 18 pax)                    530.00    212.00


Option 1: HRD Corp Claimable Course Scheme

A quotation together with course outlines and course agenda will be sent to you for HRD Corp grant application upon confirmation of the training. Please send us the grant application number for our record upon submission.

Option 2: Self-paying

2a) Direct Bank-in or via E-Banking

An invoice will be sent to you within 3 working days upon your registration. Please note that any Early Bird Discounts (for registration within validity period) will be reflected in the invoice. Please email us ( the bank-in slip / remittance slip once the payment is made.

Please refer the following bank account details:
Beneficiary Name: Medsociate Sdn Bhd
Bank Account Number: 230-302-078-2
Bank: UOB Bank
Swift Code: UOVBMYKL

For Government Sector –
A Local Order (LO) or letter of approval to participate must be submitted before your registration can be confirmed.

2b) Direct Online Payment
You may choose to make credit card payment via Paypal. An invoice with payment link will be sent to your email address separately when you choose this option.

The organisers, AMMI/Medsociate Sdn Bhd reserves the right to cancel or postpone any training or event but with due notice to the registered participants / company(s). Any payment made will be refunded in full if the cancellation is made by AMMI/Medsociate Sdn Bhd. No shows and cancellations made by participants/ companies within the specified period will incur the specified costs as per below schedule.


Prior to Training Date Cancellation Charges
30 days or more  No charges
15-29 days 25% of training course fee 
8 – 14 days 50% of training course fee
0 – 7 days 100% of training course fee


Replacement of participant is allowed at no additional cost if you are unable to attend. Please inform us of the replacement in writing at least 3 working days before the training date.

For enquiries, please email to Medsociate Sdn Bhd
Authorised training provider of AMMI


Tel: +6010 4040 662


2022 AMMI Public Training Wish List

You are invited to submit your 2022 training wishlist and we will turn the most requested courses into public training classes for you!

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, 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 HERE
Ciba Vision Johor Sdn BhdGelang Patah,

Fresenius Medical Care Production Sdn BhdNegeri Sembilanwww.freseniusmedicalcare.myCLICK HERE
KLS Martin Malaysia Sdn BhdSimpang Ampat, Penangwww.klsmartin.comCLICK HERE
Paramit.Tecan Malaysia 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, 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


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.


  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

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.

Knowledge about quality management system for Medical Device Industry (ISO 13485:2016) would be beneficial.

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:

  1. Support continuous development of a skilled and adaptable workforce;
  2. Increase awareness of opportunities in the medical technology sector
  3. Facilitate the transfer and sharing of knowledge within our industr

Key initiatives to achieve its talent development objectives  are  through implementation of the following:

  1. Medtech training
  2. Global expert knowledge sharing
  3. Collaboration with higher education institutes
  4. 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.