Category Archives: Uncategorized

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

 

Course Title: Effective Complaint Handling for Medical Devices

SOCSO Course Category: Manufacturing

SOCSO Course Code: HIT3056

INTRODUCTION
The medical device industry is highly regulated due to the product risk to health and this risk is as well an important factor in complaint handling. This training program on medical device complaint handling is based on FDA regulations and the regulatory process as well as requirements from ISO 13485:2016 and MDR with respect to Medical Device Complaint Handling, including processes related to NCR and CAPA.

COURSE OBJECTIVE
This course will provide participants with an overview about handling of Medical Device Complaints, from receiving complaints, registration, classification, investigation, initiating and following up of corrective actions until reporting and closing of a complaint.

COURSE OUTLINE

1. Requirements of Regulations and Standards (USFDA 21 CFR Part 820; ISO 13485:2016; MDR) related to Handling of Complaints
2. Sources of Complaints, NCRs and CAPAs
3. Selection criteria NCR/CAR/CAPA
4. Complaint Handling – structure, templates & process flows
5. Root Cause analysis / Problem solving tools
6. Reporting to regulatory authorities
7. Recall decision and process

TARGET AUDIENCE
Executives and managers and also quality personnel – anyone who may involve in the handling of complaints.

PRE-REQUISITE
Participants should have experience with or basic knowledge of quality management systems for the medical device industry. Basic awareness on medical devices, quality assurance and recognized standards (USFDA 21 CFR Part 820 & ISO 13485:2016) is also recommended.

 

DURATION
Two (2) full days

TRAINER’S PROFILE
Frank Ried is a German national living and working in Malaysia for more than 20 years. He holds a Mechanical Engineering Degree (Dipl. Ing.) from University of Kassel/Hessen (Germany). Frank is a Quality Engineer and Quality Auditor certified by EOQ (European Organisation of Quality) and DGQ (Deutsche Gesellschaft fuer Qualitaet). He is trained as Lead Auditor for ISO 9001, ISO 13485 and USFDA 21 CFR Part 820 requirements and has vast experience auditing and setting up compliance systems in these areas.

Frank has over 30 years of professional experience in the Medical Device manufacturing, pharmaceutical, personal protection and condom industry. He worked in two companies (B. Braun and Ansell) and various departments during this time.

Frank left Ansell at the end of 2016 to concentrate on his own company, Ried Q&C Consulting Sdn. Bhd., which he founded in early 2015. Frank now provides consultation in the compliance areas of ISO 9001, ISO 13485 and QSR (FDA) for Medical Device companies in Malaysia as well as Asia Pacific, fully utilising his expertise and experience in Quality Management, Assurance and Control. He also conducts training course as well as internal audits (incl. Mock-FDA Inspections) and supplier audits.