Category Archives: Upcoming Training and Workshops

12 October 2020: International Consensus Standards for Sterile Packaging Meeting Regulatory Requirements

AMMI Global Expert Webinar: International Consensus Standards for Sterile Packaging Meeting Regulatory Requirements

Date: 12 October 2020 (Monday)
Time: 2.00pm-4.00pm

Webinar Fees:
AMMI Members-Free
Non Members-  RM100 per pax

 

The session will cover the essentials of sterile packaging validation, maintenance of sterility and other key features.

WHAT WILL YOU LEARN?

  1. The new EU Medical Device Regulation (MDR) – A summary of key aspects and the impact on Global Sterile Packaging Standards
    ISO 11607- Packaging for sterile medical devices- latest revisions Feb 2019
  2. Deep dive on Usability:
    – Aseptic presentation – risks and aspects to consider,
    – Usability evaluation for aseptic presentation,
    – New requirements for labelling of sterile packaging, new symbols
  3. ISO standard development
    – The ISO process
    – Development of ISO TS 16775 – the guidance for the application of ISO 11607-1/2
    – Future amendment to ISO 11607 for risk management

WHO SHOULD ATTEND?
This training is recommended for those who are involved in Quality Control and Regulatory Affairs, Microbiologists, R&D and Manufacturing Operations, Packaging and Process Engineering, Procurement and Supply Chain Management, Quality Control and Regulatory Affairs, Marketing and Product Management as well as Sterilization Professionals

SPEAKER PROFILE
Thierry Wagner – Global Director of Regulatory and Standards

Products—Packaging” (ISO 11607), chairman of the Sterile Barrier Association (SBA), member of the Parenteral Drug Association (PDA) and actively involved in various ISO and CEN technical committees on medical and pharmaceutical packaging like CEN TC102 “Sterilizers for Medical Purposes—Packaging” (EN868) and ISO TC76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use”.

Thierry has spent over 30 years working for DuPont in its polyester films and nonwovens businesses in a variety of assignments ranging from process development and project management to operations and business management. He is the convenor of ISO TC198/WG7 “Sterilization of Health Care

Thierry is also a member of ISO/TC 210 in charge of ISO 13485, medical device symbols, ASTM Committee F02 and of the CEN Advisory Board for Healthcare Standards-Europe (CEN ABHS). He earned a master’s degree in mechanical and process engineering from ETH Zürich in Switzerland. He is a featured speaker at international conferences and seminars on medical and pharmaceutical packaging regulatory aspects.

27-28 October 2020: Risk Management for Medical Devices (EN ISO14971 : 2019)

RISK MANAGEMENT FOR MEDICAL DEVICES (EN ISO14971:2019)
Date: 27 & 28 October 2020
Time: 9am – 5pm
Venue: Majestic Hotel, Kuala Lumpur

 

COURSE FEES

Early Bird Course Fees (until 13 Oct)
AMMI Member: RM 1,272.00 per pax
Non Member: RM 1,484.00 per pax

Normal Course Fees (from 14 Oct onwards)
AMMI Member: RM 1,484.00 per pax
Non Member: RM 1,696.00 per pax

INTRODUCTION
ISO 14971 is an ISO standard for the application of risk management to medical devices. ISO 14971:2019 was released mid-December, and the EN version was released on December 18, 2019 to replace the ISO 14971:2007 and EN ISO 14971:2012 respectively.

Main highlighted of the updates are as follows:

  • The key concepts and core approach to risk management was maintained
  • Clarification was added around the following:
    Production and post-production information
    Clinical benefits and risk-benefit analysis
    Update the guidance in the annexes
    Revise ISO/TR 24971- The Technical Report that provides guidance on the application of ISO 14971
  • Informative Annexes would primarily reside in ISO TR 24971 because it is easier to update a Technical Report than it is a standard. A new Clause was added: Clause 2 on Normative References. As a result, all Clauses past Clause 1 are incremented by 1.
  • While the Technical Report complements the standard, it is important to note that the information in ISO TR 24971:2019 serves only as a guidance, and not requirements. As well, the first 3 annexes in ISO 14971:2019 act as guidance, and not requirements. The ISO/TR 24971:20XX has not been released yet.

COURSE OBJECTIVE

This training aims to provide participants with a clear understanding and insight into the new EN ISO 14971:2019 requirements. The training takes a look at what the major changes in 2019 updates/revision and also covers some of the commonly used risk management tools such as FMEA, FTA etc.

COURSE OUTLINE

Day 1:

  1. Understand basic principles of risk management
  • Standards & Regulation
  • What is Risk Management
  • The Importance
  • When to Initiate
  • Use of Risk Management

 

  1. EN ISO 14971:2019 Requirements
  • Scope
  • Normative Reference
  • Terms and Definition
  • Clause 4.1 Risk Management Process
  • Clause 4.2 Management Responsibilities
  • Clause 4.3 Competence of Personnel
  • Clause 4.4 Risk Management Plan
  • Clause 4.5 Risk Management File
  • Clause 5 Risk Analysis
  • Clause 6 Risk Evaluation
  • Clause 7 Risk Control
  • Clause 8 Evaluation of Overall Residue Risk
  • Clause 9 Risk Management Review
  • Clause 10 Production and Post Production Activities

 

Day 2

  1. EN ISO 14971:2019 Background
  2. EN ISO 14971:2019 vs EN ISO 14971:2012 vs EN ISO 14971:2009 vs ISO 14971:2007
  3. Highlighted changes in EN ISO 14971:2019 vs EN ISO 14971:2012
  4. ALARP Concept
  5. Summary

 

TARGET AUDIENCE
Professionals from quality assurance, regulatory affairs, research and development, process improvement, manufacturing and others who involve and wish to understand how to apply and develop proper risk management documentation for product and process of medical device industry.

PRE-REQUISITES
Basic understanding of the ISO 13485:2016 and use of risk management tools such as FMEA is an added advantage. Previous knowledge of ISO 14971:2007 or EN ISO 14971:2012 is not required.

DURATION
Two (2) full days

TRAINER’S PROFILE

Harry Wong has over 19 years’ of professional work experience in Quality Assurance of medical device, Ceramic Former and Metal Stamping for Electrical, Electronics and Automotive industries. He currently holds the position of Associate Director, Global Complaint and Risk Management, Global Quality Assurance in one of the global leaders in protection solutions. As the subject matter expert of risk management, he provides advice, direction and training for Risk Management personnel across global sites and facilities; ensuring their risk management process complies with all necessary regulatory standards including QSR (FDA), MDD and ISO requirements. He is responsible for developing the global harmonized risk management SOP and tools which are implemented in the global organization facilities and sites.

Harry Wong is also an ASQ Certified Quality Engineer and Lead Auditor for ISO 9001 and ISO 13485 and has extensive involvement in mock audits for global sites preparing for CCC, ANVISA, SEI and FDA.

PAYMENT AND CONFIRMATION OF REGISTRATION

All payment is due immediately upon receipt of invoice. Please note that a confirmation letter for HRDF submission will only be issued upon receipt of payment.

Option 1:  Direct Bank-in or via E-Banking upon receipt of Invoice

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 (admin@medsociate.com) the bank-in slip / remittance slip once the payment is made. A confirmation letter for your HRDF submission will be issued to you upon receipt of payment.

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.

 Option 2: Direct Online Payment
You may choose to make direct online payment, via Paypal or your credit/ debit card. A tax invoice and confirmation letter will be sent to your email address within 3 working days, when you choose this option. 

CANCELLATION / REFUND POLICY
AMMI 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.  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

 

SUBSTITUTION

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.

CONTACT
For enquiries, please email to secretariat@ammi.com.my
Tel: +6010 4040 662  Fax: +603 2178 4347

5 November 2020: Introduction to EtO Sterilization for Medical Devices

INTRODUCTION TO ETO STERILIZATION FOR MEDICAL DEVICES

Date: 5 November 2020
Venue: G Hotel Gurney Penang
Time: 9.00am-5.00pm

COURSE FEES
Early Bird Fees (Registration until  16 October)
AMMI Members: RM742 (inc 6% SST)
Non Members: RM848 (inc 6% SST)

Normal Fees (Registration from 17 October onwards)
AMMI Members: RM848 (inc 6% SST)
Non Members: RM954 (inc 6% SST)

INTRODUCTION

Medical device manufacturing is both demanding and complex. The training course is designed to create better understanding of the Ethylene Oxide (EtO) sterilization process for the medical device manufacturing professionals in Malaysia.

 

COURSE OBJECTIVE

This course will give participants an overview of the EtO sterilization process, such as validation & standard, EtO routine process control, EtO residuals, safety & environmental control, handling EtO gas and biological indicator 

COURSE OUTLINE

  1. Introduction
  2. Requirements for Validation of EO – ISO 11135
  3. EO Sterilizer Operation and EO Cycles
  4. Getting started on a new Microbiological validation
  5. Re-Qualification of EO – requirements of 11135 and TIR 28
  6. Other parts of the validation; EO residuals, packaging, etc..
  7. Problem Solving by Groups


TRAINER PROFILE

Mr Roslan Azman has more than 12 years’ experience in sterilisation – with extensive work experience in Medical Device Sterilization, specialising in EtO, and Gamma Sterilization as well as Medical Packaging. His experience was gained through his tenure with multinational med tech company, B Braun Medical Industries Sdn Bhd. In addition to sterilisation expertise, he also has experience in pharmaceutical quality control. He holds a degree in Applied Chemistry and diploma in microbiology from University Technology MARA.

TARGET AUDIENCE
Quality and regulatory affairs managers, engineers, technicians involved in the development, manufacturing and packaging of medical devices

DURATION
One (1) full day 

PAYMENT AND CONFIRMATION OF REGISTRATION
All payment is due immediately upon receipt of invoice. Please note that a confirmation letter for HRDF submission will only be issued upon receipt of payment.

Option 1: Direct Bank-in or via E-Banking upon receipt of Invoice
An invoice will be sent to you within 3 working days upon your registration.  Please note that any Early Bird Discounts (for registration within the validity period) will be reflected in the invoice. Please email us (admin@medsociate.com) the bank-in slip/remittance slip once the payment is made. A confirmation letter for your HRDF submission will be issued to you upon receipt of payment.

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. 

Option 2: Direct  Online Payment
You may choose to make a direct online payment, via Paypal or your credit/ debit card. A tax invoice and confirmation letter will be sent to your email address within 3 working days, when you choose this option.

CANCELLATION / REFUND POLICY
AMMI 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.  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

SUBSTITUTION
Replacement of the 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.

CONTACT
For enquiries, please email to secretariat@ammi.com.my
Tel: +6010 4040 662  Fax: +603 2178 4347

19-20 November: Medical Device Design Control

MEDICAL DEVICE DESIGN CONTROL
Date: 19-20 November 2020
Time: 9am – 5pm
Venue: G Hotel, Penang

COURSE FEES

Early Bird Course Fees (until 4 Nov)
AMMI Member: RM 1,272.00 per pax
Non Member: RM 1,484.00 per pax

Normal Course Fees (from 5 Nov onwards)
AMMI Member: RM 1,484.00 per pax
Non Member: RM 1,696.00 per pax

INTRODUCTION

Design Control is a substantial element of Quality System Regulation FDA 21 CFR Part 820 and ISO 13485 standards for medical device industries. Manufacturers must establish a robust design control processes to ensure develop a safe and effective finished product thus complies to regulatory requirements. This interactive course engages the participants with in-depth discussion of industry best practices to learn how industry leaders address design control challenges.

 

COURSE OUTLINE

1. Regulatory/QMS Compliance

1.1. QSR-21 CFR Part 820/EU MDR 2017/745

1.2. ISO 13485:2016, GHTF.SG3.N99-9

 

2. Introduction to Design Control

2.1. What is Medical Device Design Control Process

2.2. Application of Design Control-Waterfall Design Process

 

3. Medical Device Classification

3.1. European Medical Device Classification

3.2. US FDA Device Classification

 

4. Implementing Design Control

4.1 Design & Development planning [21 CFR 820.30 (b)]

4.2 Design Inputs [21 CFR 820.30 (c)]

4.3 Design Outputs [21 CFR 820.30 (d)]

4.4 Design Reviews [21 CFR 820.30 (e)]

4.5 Design Verification [21 CFR 820.30 (f)]

4.6 Design Validation [21 CFR 820.30 (g)]

4.7 Design Transfer [21 CFR 820.30 (h)]

4.8 Design Changes [21 CFR 820.30 (i)

4.9 Design History file [21 CFR 820.30 (j)]

 

5. Principles of Risk Management for Medical Device Design

5.1 Integration of risk management into the design and development lifecycle

5.2 Integration of risk assessment/risk management/ per ISO 14971:2019

 

6. Design Control and Usability Engineering

6.1 Application of usability engineering in medical device design

 

7. Design Control – Quality System Inspection Technique

7.1 QSIT inspection techniques for Design control

 

8. Design Control Case Studies

8.1 Design control scenarios

 

TARGET AUDIENCE

  • Regulatory Personnel
  • Quality Engineers
  • Quality System Auditors
  • Management representatives
  • R & D staff
  • Risk Management Team members

 

PRE-REQUISITES
Basic knowledge of medical devices and quality systems would be beneficial.

DURATION
Two (2) full days

TRAINER’S PROFILE

Mr. Gobu Devarajan possesses Master Degree in Electrical and Electronic Engineering and Certified Manager of Quality/Organizational Excellence (CMQ/OE, Certified Quality Auditor (CQA) from American Society of Quality (ASQ). Certified Six Sigma Green Belt.

He has more than twenty five years of working experience with extensive knowledge in the field of Quality Engineering, Statistical Analysis and Quality System Requirements. He possesses excellent communication and presentation skills. He is capable of designing, conducting training programs and perform gap analysis according to QSR (21 CFR Part 820), ISO 13485, ISO 9001, ISO 16949 and ISO 14971. MDD 93/42/EEC, CMDCAS and JPAL

PAYMENT AND CONFIRMATION OF REGISTRATION

All payment is due immediately upon receipt of invoice. Please note that a confirmation letter for HRDF submission will only be issued upon receipt of payment.

Option 1:  Direct Bank-in or via E-Banking upon receipt of Invoice

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 (admin@medsociate.com) the bank-in slip / remittance slip once the payment is made. A confirmation letter for your HRDF submission will be issued to you upon receipt of payment.

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.

 Option 2: Direct Online Payment
You may choose to make direct online payment, via Paypal or your credit/ debit card. A tax invoice and confirmation letter will be sent to your email address within 3 working days, when you choose this option. 

CANCELLATION / REFUND POLICY
AMMI 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.  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

 

SUBSTITUTION

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.

CONTACT
For enquiries, please email to secretariat@ammi.com.my
Tel: +6010 4040 662  Fax: +603 2178 4347