Category Archives: Upcoming Training and Workshops

9-10, 23-24 June 2021: Software Validation Requirements & Excel Spreadsheet Validation

Software Validation Requirements & Excel Spreadsheet Validation

This course is HRDF SBL-Khas Scheme Claimable

DATE
9-10, 23-24 June 2021:

DURATION
4 half-day courses (4 hours per session)

DELIVERY MODE
Online Training

TIME
8.30am-12.30pm

INTRODUCTION / OBJECTIVES

Software Validation Requirements and Excel Spreadsheet Validation is a formalized, documented process for testing computer software and systems. The FDA and other regulatory bodies require Software and Excel Spreadsheet Validation to demonstrate that computer systems are in compliance with all regulations for electronic data management systems.  Software and excel spreadsheets used in GMP or GLP environments, as with any computer system, the regulatory bodies  expects measures to be in place to ensure system data are controlled and protected and to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. This training session shall explore the requirements for Software and Excel spreadsheets used in production or the quality system and case studies on how verification/validation can be accomplished.

COURSE OUTLINE

  1. Overview of Excel Validation System

1.1. Regulatory and QMS Requirements

1.2. Introduction to GAMP 5 requirements

1.3. 21 CFR Part 11 Regulations

 

  1. Types of Software/Computer Validation System

2.1. Computer System

2.2. Information System

2.3. Control System

2.4. Design system

 

  1. Software Category

3.1. Category 1 – Operating System

3.2. Category 3 – Standard Software Packages

3.3. Category 4 – Configurable Software Systems

3.4. Category 5 – Custom Built or Bespoke Systems

  1. Excel Spreadsheet Development Lifecycle

4.1. Project Planning.

4.2. Design

4.3. Development

4.4. Integration and Test

4.5. Installation and Acceptance

 

  1. Elements of Excel Spreadsheet Verification and Validation

5.1. Validation Master Plan

5.2. User Requirement Specification (URS)

5.3. Functional Requirement Specification (FRS)

5.4. Design Specification (DS)

5.5. Installation Qualification (IQ)

5.6. Operational Qualification (OQ)

5.7. Performance Qualification (PQ)

  1. Case Studies + Discussion

6.1. The “V” Model and how to apply it to software

6.2. Development of URS, FS, DS & Test Cases

6.3. Development of IQ, OQ and PQ protocols

6.4. Development of IQ, OQ and PQ report

 

TARGET AUDIENCE

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

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

 

 

Early Bird Prices (Register by 7 May 2021)
AMMI Member: RM1,272.00 per pax (incl 6% SST)
Non Member: RM 1484.00 per pax (incl 6% SST)

Normal Fees (Register from 8 May 2021 onwards)
AMMI Member: RM1,484 per pax (incl 6% SST)
Non Member: RM1,696.00 per pax (incl 6% SST)

Option 1: HRDF Claim under SBL-Khas Scheme
A quotation together with course outlines and course agenda will be sent to you for HRDF 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 (admin@medsociate.com) 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

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.

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

Email: admin@medsociate.com

Tel: +6010 4040 662

Fax: +603 2178 4347

9-10, 23-24 June 2021: Medical Device Manufacturing Process Validation

Medical Device Manufacturing Process Validation

This course is HRDF SBL-Khas Scheme Claimable

DATE
9-10, 23-24 June 2021:

DURATION
4 half-day courses (4 hours per session)

DELIVERY MODE
Online Training

TIME
1.30pm – 5.30pm

INTRODUCTION

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

 

COURSE OBJECTIVES

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.

COURSE OUTLINE

  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

 

TARGET AUDIENCE

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

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

 

 

Early Bird Prices (Register by 7 May 2021)
AMMI Member: RM1,272.00 per pax (incl 6% SST)
Non Member: RM 1484.00 per pax (incl 6% SST)

Normal Fees (Register from 8 May 2021 onwards)
AMMI Member: RM1,484 per pax (incl 6% SST)
Non Member: RM1,696.00 per pax (incl 6% SST)

Option 1: HRDF Claim under SBL-Khas Scheme
A quotation together with course outlines and course agenda will be sent to you for HRDF 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 (admin@medsociate.com) 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

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.

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

Email: admin@medsociate.com

Tel: +6010 4040 662

Fax: +603 2178 4347

24-25 May, 7-8 June 2021 Risk Management (ISO14971:2019) -Intermediate Level

Risk Management for Medical Devices (ISO14971:2019)
Intermediate Level

This course is HRDF SBL-Khas Scheme Claimable

Due to popular demand, we have opened an additional training class. Sign up now before seats are filled. 

DATE
24-25 May, 7-8 June 2021

DURATION
4 half-day courses (4 hours per session)

DELIVERY MODE
Online Training

TIME
8.30am-12.30pm

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 is 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

Session 1 & 2 (2 half-day):

EN ISO 14971:2019 Requirements

  • Clause 1 Scope
  • Clause 2 Normative Reference
  • Clause 3 Terms and Definitions
  • Clause 4 General Requirements for Risk Management System
  • 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

 

Session 3 & 4 (2 half-day)

EN ISO 14971:2019 Requirements (continue)

  • Clause 8 Evaluation of Overall Residue Risk
  • Clause 9 Risk Management Review
  • Clause 10 Production and Post-Production Activities

– Review on EN ISO 14971:2012 Annex Z on Potential New Annex in EN ISO 14971:20XX

– ALARP Concept

– Summary

– Extra Information

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.

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.

Early Bird Prices (Register by 26 April 2021)
AMMI Member: RM1,272.00 per pax (incl 6% SST)
Non Member: RM 1484.00 per pax (incl 6% SST)

Normal Fees (Register from 27 April 2021 onwards)
AMMI Member: RM1,484 per pax (incl 6% SST)
Non Member: RM1,696.00 per pax (incl 6% SST)

Option 1: HRDF Claim under SBL-Khas Scheme

A quotation together with course outlines and course agenda will be sent to you for HRDF 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 (admin@medsociate.com) 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

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.

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

Email: admin@medsociate.com

Tel: +6010 4040 662

Fax: +603 2178 4347

13-14, 21-22 April 2021- EUMDR Intermediate Level

EU Medical Device Regulations (EU MDR 2017/745)
Intermediate Level

This course is HRDF SBL-Khas Scheme Claimable

Registration is now closed. For enquiries, please email: secretariat@ammi.com.my

DATE
13-14, 21-22 April 2021

TIME
8.30am – 12.30pm

DURATION
4 half-day courses (4 hours per session)

DELIVERY MODE
Online Training

OVERVIEW

The EU Medical Device Regulation (MDR) 2017/745 was published on 5th May 2017, and it has replaced the EU Medical Device Directive (MDD 93/42/EEC) and the EU Active Implantable Medical Device Directive (AIMDD 90/385/EEC). It came into force on the 25th May 2017, and all the related and relevant manufacturers have three years transition period to comply with the EU MDR. However, the European Parliament has adopted and supported the European Commission’s proposal to postpone the effective compliance and application of the EU MDR to 26th May 2021 due to the Covid-19 outbreak.

The 175-pages document outlined regulatory requirements to the economic operators (a manufacturer, an authorized representative, an importer and/or a distributor) as well as the notified bodies. The EU MDR also outlined the Rules (with added Rules compared to the previous EU Medical Device Directive) for medical device classification purposes.

The EU MDR compliance is important and mandatory for all existing economic operators that involved in marketing medical devices in the EU market as well as all economic operators who wish to expand their medical device distribution into the EU market.

COURSE OBJECTIVES

This course aims to give delegatesin-depth knowledge regarding the EU Medical Device Regulation and the course content outlined is to provide delegates with information on:

  • The structure of the EU Medical Device Regulation
  •  Who shall comply with the EU Medical Device Regulation
  • The Rules and Classifications of the medical devices
  • The Technical Documentation (Annex II and III of the EU MDR)
  • Clinical Investigation and Evaluation
  • Conformity assessment procedures

COURSE OUTLINE

Session 1 (half-day):

Opening and introduction

1.          Background of the EU Medical Device Regulation and its Structure

2.          The role and responsibilities of the economic operators

3.          Person Responsible for Regulatory Compliance

4.          Medical device Rules and Classifications

 

Session 2 (half-day):

Day 1 Recap

4.          Medical device Rules and Classifications (Continue)

5.          Risk Management and Technical Documentation

 

Session 3 (half-day):

Day 2 Recap

5.          Risk Management and Technical Documentation (Continue)

6.          Clinical Investigation and Evaluation

 

Session 4 (half-day):

Day 3 Recap

7.          Conformity assessment procedures

8.          Course summary

COURSE BENEFITS

Upon completion of this training, delegates will have the knowledge on: –

  1. The purpose and structure of the EU MDR
  2. Who should be the appointed the Person Responsible for Regulatory Compliance
  3. Added Rules in the EU MDR for medical devices classifications
  4. The requirements on Risk Management Process and Technical Documentation
  5. The requirements on Clinical Investigation and Evaluation
  6. The different assessment route in accordance to Article 52 – Conformity assessment procedures

TARGET AUDIENCE

This program is very useful to delegates who handles EU MDR compliance and actively involved in EU MDR compliance planning and execution. However, this program is not restricted only to Quality and Regulatory Affairs personnel, personnel from other functions such as Design and Production will be benefited from this program as well.

Kenny Chong is the General Manager at Quintas Consulting Sdn Bhd where his role also includes maintaining top quality training, consultancy and coaching service for Medical Device & other regulated industries.  He has been involved in the Medical Device Industry for the past 14 years, working with Straits Orthopaedics, Symmetry Medical, Neville-Clarke as well as BSI Services. In this time, his experience throughout the entire product lifecycle and all 3 medical device regulatory stages has enabled him to gain qualification on all medical device technology scopes.

He is a trained CQI & IRCA Lead Auditor of ISO 9001:2015, ISO 14001:2015, OHSAS 18001:2007 as well as ISO13485:2016. He has also attended and passed training on Conformity Assessment Procedures on Quality Management System & Post Market Surveillance by the Medical Device Authority, Malaysia.

Early Bird Prices (Register by 8 April 2021)
AMMI Member: RM 1,272.00 per pax (incl 6% SST)
Non Member: RM 1,484.00 per pax (incl 6% SST)

Normal Fees (Register from 9 April 2021 onwards)
AMMI Member: RM 1,484.00 per pax (incl 6% SST)
Non Member: RM 1,696.00 per pax (incl 6% SST)

Option 1: HRDF Claim under SBL-Khas Scheme

A quotation together with course outlines and course agenda will be sent to you for HRDF 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 (admin@medsociate.com) 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

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.

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

Email: admin@medsociate.com

Tel: +6010 4040 662

Fax: +603 2178 4347

21-22 April 2021- MDSAP Beginner Level

Medical Device Single Audit Program (MDSAP)
Beginner Level

This course is HRDF SBL-Khas Scheme Claimable

DATE
21-22 April 2021

TIME
1.30pm – 5.30pm

DURATION
2 half-day courses (4 hours per session)

DELIVERY MODE
Online Training

OVERVIEW

The Medical Device Single Audit Program (MDSAP) was the initiative from the International Medical Device Regulators Forum (IMDRF). Developed to enhance the auditing and monitoring approach of medical devices manufacturing globally, MDSAP went through a 3-year pilot project from 1st January 2014 until 31st December 2016 and became a full program from 1st January 2017.

There are currently 5 MDSAP members and they are:

  1. Therapeutic Goods Administration (TGA) of Australia
  2. Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
  3. Health Canada (HC)
  4. Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency (MHLW/PMDA)
  5. S. Food and Drug Administration (FDA)

The MDSAP requirements are developed based on the 5 MDSAP members’ country’s regulated policies for medical devices with ISO 13485 Quality Management System requirements as the basis. The MDSAP certification audit is performed by approved and authorized Auditing Organizations (AO) and the MDSAP certification is on a 3-year cycle.

COURSE OBJECTIVES

This course aims to give delegates an overview of the Medical Device Single Audit Program (MDSAP) and the course content outlined is to provide delegates with:

  • Introductory knowledge of MDSAP
  • Introduction of the 7 processes in MDSAP
  • The advantages of MDSAP certification

COURSE OUTLINES

  1. Development of Medical Device Single Audit Program (MDSAP)
  2. The overview of 7 processes in the MDSAP
  3. MDSAP Certification

COURSE BENEFITS

Upon completion of this training, delegates will: –

  1. Be able to understand the structure and purpose of MDSAP
  2. Be able to have some decisional pointers if the organization shall be MDSAP certified

TARGET AUDIENCE

This program is useful to delegates (regardless of their job role and responsibilities) who are new to the Medical Device Single Audit Program (MDSAP). Top Management personnel are also encouraged to enroll to this program to understand the MDSAP at a high-level view.

Kenny Chong is the General Manager at Quintas Consulting Sdn Bhd where his role also includes maintaining top quality training, consultancy and coaching service for Medical Device & other regulated industries. He has been involved in the Medical Device Industry for the past 14 years, working with Straits Orthopaedics, Symmetry Medical, Neville-Clarke as well as BSI Services. In this time, his experience throughout the entire product lifecycle and all 3 medical device regulatory stages has enabled him to gain qualification on all medical device technology scopes.

He is a trained CQI & IRCA Lead Auditor of ISO 9001:2015, ISO 14001:2015, OHSAS 18001:2007 as well as ISO13485:2016. He has also attended and passed training on Conformity Assessment Procedures on Quality Management System & Post Market Surveillance by the Medical Device Authority, Malaysia.

Early Bird Prices (Register by 22 March 2021)
AMMI Member: RM636.00 per pax (incl 6% SST)
Non Member: RM 742.00 per pax (incl 6% SST)

Normal Fees (Register from 23 March 2021 onwards)
AMMI Member: RM 742.00 per pax (incl 6% SST)
Non Member: RM 848.00 per pax (incl 6% SST)

Option 1: HRDF Claim under SBL-Khas Scheme

A quotation together with course outlines and course agenda will be sent to you for HRDF 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 (admin@medsociate.com) 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 a 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

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.

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

Email: admin@medsociate.com

Tel: +6010 4040 662

Fax: +603 2178 4347