China CFDA - GMPs

China Food and Drug Administration’s (CFDA’s) – GMP for Implantable Medical Devices

This course focuses on providing an understanding of the Chinese Food and Drug Administration’s (CFDA’s) Announcement on issuing an Appendix of Implantable Medical Devices to Good Manufacturing Practices for Medical Devices, 2015 Number 102. These regulations are outlined in four parts which will be covered in this course. The purpose of this course is to present the regulations in a clear and concise manner in order to provide participants with the necessary information required to maintain the safety and efficacy of medical devices as specified by the CFDA.

CEU Credits: 0.1

Course Code: ELM-331

Duration: 60 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Introduction

Overview

Who Should Take This Course?

Learning Objectives

Introduction to CFDA Appendix to GMPs for Implantable Medical Devices

Supplementary Provisions (Part 4)

Terminology (Part 3)

Part 1: Scope and Principles

Part 2: Introduction to Special Requirements

2.1 Personnel

Education and Training

Hygiene, Health, and Clothing Requirements

2.2 Workshops and Facilities

General Requirements

Acceptable Cleanliness Levels Part 1

Acceptable Cleanliness Levels Part 2

Clean Room Environment

Plumbing, Pest Control, and Other Environmental Requirements

2.3 Equipment

2.3 Equipment

2.4 Design and Development

2.4 Design and Development

2.5 Procurement

General Requirements

Implantable Animal-Derived Medical Devices

Implantable Allogenic Medical Devices

2.6 Manufacturing Management

General Requirements

Sterilization

Traceability

Packaging and Storage

Animal-Derived and Allogenic Medical Devices

Cleaning, Disinfection, and Pest Control

2.7 Quality Control

2.7 Quality Control

2.8 Marketing

2.8 Marketing

2.9 Monitoring, Analysis, and Improvement of Adverse Events

2.9 Monitoring, Analysis, and Improvement of Adverse Events

Conclusion

Final Assessment

Certification

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

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