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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

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.

Introduction to Medical Device Industry

SOCSO Course Category:
Manufacturing

SOCSO Course Code:
HIT3043

Course Title:
Introduction to Medical Device Manufacturing

Duration:
3 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 Attendance

Certification body:
Association of Malaysian Medical Industries (AMMI)

Course Objectives:
Introduction to Medical Device Manufacturing aims to upskill new hires on the requirements of the medical device manufacturing industry. This includes the understanding of the medical device industry and the significance of quality and regulatory compliance; importance of Good Manufacturing Practice, Good Documentation Practice.

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

Course Content:
• Introduction to Medical Device Industry and Quality Mind-set
• Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP)
• Importance of Safety in Medical Device Manufacturing Environment

Learning Outcomes:
Upon successful completion of the training, participants will be able to:
• Have a general overview of Medical Device Industry and the quality systems that govern the industry
• Understand basics of GMP and GDP
• Understand safety practices in the manufacturing environment

Medtech Foundation Programme

SOCSO Course Category:
Manufacturing

SOCSO Course Code:
HIT 3042

Course Title:
Medtech Foundation Course

Duration:
5 Days

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

Target Industry:
Medical Device Manufacturing Industry

Certification:

  • Certificate of Competency in Medtech Foundation Course will be awarded to participants upon the passing of final assessment (60 marks and above)
  • Certificate of Attendance in Medtech Foundation 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 Foundation Course aims to accelerate skills of new hires to meet the needs of companies that require professionals with knowledgeable about medical device industry. Participants will be exposed to the regulated medical device industry and the quality system that governs the industry.

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

Course Content:
• Introduction to Medical Device Industry and Quality Mind-set
• Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP)
• Importance of Safety in Medical Device Manufacturing Environment
• Cleanroom Contamination Control & Personnel Hygiene Control
• 5S in Medical Device Industry

Learning Outcomes:
Upon successful completion of the training, participants will be able to:
• Have an general overview on Medical Device Industry and the quality systems that governs the industry
• Understand basics of GMP and GDP
• Understand essential principles of safety in the manufacturing environment
• Understand fundamental information for cleanroom operations
• Understand sources of contamination and safety practices in cleanroom
• Have a practical understanding of the 5S principles and how it can be applied to the organisation

Medtech Upskilling Programme

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