Category Archives: Uncategorized

Medtech Upskilling Course

SOCSO Course Category:
Manufacturing

SOCSO Course Code:
HIT3041

Course Title:
Medtech Upskilling Course

Duration:
7 Days

Target Group:
For retrenched workers to learn new skills and enable them to work again.

Target Industry:
Medical Device Manufacturing Industry

Certification:

  • Certificate of Competency in Medtech Upskilling Course will be awarded to participants upon the passing of final assessment (60 marks and above)
  • Certificate of Attendance in Medtech Upskilling Course will be awarded to the participants if they failed the final assessment (60 marks and below)
  • Certification body: Association of Malaysian Medical Industries (AMMI)

Course Objectives:
The Medtech Upskilling Course aims to develop, enhance and certify skills and knowledge of unemployed Malaysian on the requirements of the medical industry. This includes the understanding of the medical industry and the significance of quality and regulatory compliance; key medical device regulatory systems; importance of Good Manufacturing Practice, Good Documentation Practice; ISO13485 standard and implications; manufacturing essential practices and implications.

Methods/ Methodology Course :
Lecture
Case Studies
Pre-Test and Post-Test

Course Content:
• Overview of Medical Device Classification, Labelling and CE Marking
• ISO 13485 Quality Management System and 21 CFR Part 820
• EN ISO 14971 Risk Management
• Process Validation for Medical Devices

Learning Outcomes:
Upon successful completion of the training, participants will be able to:
• Understand the medical industry and its practices, regulations and compliance requirements
• Knowledge on the Medical Device Regulatory System
• Knowledge on the Medical Device Classification and the differences in requirements and practices
• Learn and understand the importance of Good Manufacturing Practice and the importance of adherence for quality and patient safety
• Learn and understand the importance of Good Documentation Practice for traceability and impact on quality and patient safety
• Knowledge on bio burden and microbiology control; effects of bio burden and microbiology control on product quality and patient safety; outcomes and impact of improper control
• Understand the Production Process change controls, validation, qualification and the significance of ability to maintain the changed processes
• Learn the importance of labelling requirements and the consequences of non-adherence and wrong labelling to product and patient safety
• Learn about audits and its requirements, guidelines and preparedness
• Equipped with patient safety, quality and compliant mindset as the basis for a competent medtech employee

 

Understanding and Implementing Medical Device Single Audit Programme (MDSAP)

SOCSO Course Category:
Manufacturing

SOCSO Course Code:
HIT3049

Course Title:
Understanding & Implementing Medical Device Single Audit Program (MDSAP)

Duration:
2 Days

Target Group:
Managers, Engineers, Internal Auditors and Exempt-staffs.

Target Industry:
Medical Device Manufacturing Industry

Certification:
Certificate of Attendance in Understanding & Implementing Medical Device Single Audit Program (MDSAP) by the Association of Malaysian Medical Industries

Course Objectives:
The MDSAP (Medical Device Single Audit Program) is an audit program where a medical device manufacturer’s QMS to be audited once by an Audit Organization for compliance with the ISO 13485:2016 and up to five country-specific (Australia, Brazil, Canada, Japan and the United States).  This course is designed to provide participants with the practical knowledge to understand and implement the MDSAP requirements. The program enables appropriate regulatory oversight of medical device manufacturers’ QMS by the Regulatory Authorities while minimizing regulatory burden on the medical devices industry.

Methods/ Methodology:

  • Lecture
  • Case Studies
  • Pre-Test & Post-Test

Course Content:

  1. Introduction to MDSAP
  2. Understanding the Audit Criteria of Management Process
  3. Understanding the Audit Criteria of Device Marketing Authorization & Facility Registration Process
  4. Understanding the Audit Criteria of Measurement, Analysis & Improvement Process
  5. Understanding the Audit Criteria of Medical Device Adverse Events & Advisory Notices Reporting Process
  6. Understanding the Audit Criteria of Design & Development Process
  7. Understanding the Audit Criteria of Production & Service Controls Process
  8. Understanding the Audit Criteria of Purchasing Process
  9. Implementing MDSAP Audit Model

Learning Outcomes:
By the end of this course, participants will be able to:

  • Understand the MDSAP requirements, the Audit Model & Sequence, and the details Audit Tasks for the primary MDSAP processes and the supporting processes.
  • Implement MDSAP Audit Model during internal audit.

Medical Device Design Control

Course Title: Medical Device Design Control

SOCSO Course Category: Manufacturing

SOCSO Course Code: HIT3052

DURATION
2 days

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

 

  1. Introduction to Design Control

2.1. What is Medical Device Design Control Process

2.2. Application of Design Control-Waterfall Design Process

  1. Medical Device Classification

3.1. European Medical Device Classification

3.2. US FDA Device Classification

 

  1. 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)]

 

  1. 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 EN ISO 14971:2012

 

  1. Design Control and Usability Engineering

6.1 Application of usability engineering in medical device design

 

  1. Design Control – Quality System Inspection Technique

7.1 QSIT inspection techniques for Design control

 

  1. 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.

 

 

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

 

Introduction to Ethylene Oxide (EtO) for Medical Devices

SOCSO Course Category: Manufacturing

SOCSO Course Code: HIT3044

Course Title: Introduction to Ethylene Oxide (EtO) Sterilization for Medical Devices

Duration:1 Day

Target Group: Quality and regulatory affairs managers, engineers, technicians involved in the development, manufacturing and packaging of medical devices

Target Industry: Medical Device Manufacturing Industry

Certification: Certificate of Attendance in Introduction to Ethylene Oxide (EtO) Sterilization for Medical Devices by the Association of Malaysian Medical Industries

Course Objectives:

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.

 

Methods/ Methodology:

  • Lecture
  • Case Studies
  • Pre-Test & Post-Test

 

Course Content:

  1. Introduction to EtO Sterilization
  2. Comparison of EtO to other sterilization methods
  3. Introduction to Microorganism(s)
  4. Sterilization Process, Media & Equipment
  5. Validation of EO Sterilization Process
  6. Understanding on Sterility Assurance Level
  7. EO Residual Requirements

 

Learning Outcomes

Upon successful completion of the training, participants will have an in depth perspective and practical examples of the EtO sterilization process, such as validation & standard, EtO routine process control, EtO residuals, safety & environmental control, handling EtO gas and biological indicator.

 

 

FMEA in Medical Device Manufacturing

SOCSO Course Category:
Manufacturing

SOCSO Course Code:
HIT3045

Course Title:
Failure Mode Effects Analysis (FMEA) in Medical Device Manufacturing

Duration:
2 Days

 

Target Group:

Anyone who wants to learn a proactive method to manage and to continuously improve work processes, and to improve overall work effectiveness and efficiency

 

Target Industry:

Medical Device Manufacturing Industry

 

Certification:

Certificate of Attendance in Failure Mode Effects Analysis (FMEA) in Medical Device Manufacturing by the Association of Malaysian Medical Industries

 

Course Objectives:

This course is designed for participants who are interested in pre-empting failure risks and driving process improvement without having to deal with Statistical Tools. Participants will learn to systematically identify potential failure risks, quantify and prioritize these risks, and to work effectively in a team to identify solutions to these risks.

 

Methods/ Methodology:

  • Lecture
  • Case Studies
  • Pre-Test & Post-Test

The course will be delivered in a Workshop environment, adopting the Action Learning Methodology to increase the rate of transferring from knowledge acquisition to skill application. The emphasis is on learning by doing, and not learning by listening. Participants will experience a simulated process at the beginning of the course. Progressively, they will learn and apply the tools to improve the simulated process.

 

Course Content:

  • Types of FMEA: Design and Process FMEA
  • System and SIPOC diagrams
  • Traditional and updated FMEA template
  • Key components of FMEA: Rating scales, Risk Priority Number (RPN) & CA
  • Planning for FMEA
  • Executing Process FMEA
  • Executing Design FMEA
  • Evaluate solutions
  • Monitor and continuously improve the solutions

Learning Outcomes:

This course will enable you to differentiate between Design and Process FMEA, practise live Process and Design FMEA in class, assess risk in a systematic manner, quantify and prioritize risks with Criticality Analysis (CA), improve process within own department (point kaizen), contribute to cross-functional process improvement (flow-kaizen)  and map your current “As Is” business process.

It will also enable you to engage staff through systematic analysis and improvement, while generating solutions to eliminate or reduce failure risks – all of which will lead to improved cost, delivery and quality.