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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

SOCSO Course Category:
Manufacturing

SOCSO Course Code:
HIT 3042

Course Title:
Medtech Foundation Course

Duration:
5 Days

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

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

 

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 EN ISO 14971:2012

 

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.

 

 

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