China CFDA - GMPs

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

This course focuses on providing an understanding of the Chinese Food and Drug Administration’s (CFDA’s) Announcement on Good Manufacturing Practices for Releasing Medical Devices, 2014 Number 64. These regulations are outlined in 13 Chapters (including 84 separate articles), 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.

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CEU Credits: 0.1

Course Code: ELM-330

Duration: 60 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Introduction

Overview

1 min 01 secs

Who Should Take This Course?

1 min

Learning Objectives

1 min 11 secs

Definitions

1 min 15 secs

Introduction to CFDA GMPs for Medical Devices

52 secs

Supplementary Provisions (Chapter 13, Articles 79 – 84)

1 min 09 secs

Chapter 1: General Provisions (Articles 1 – 4)

General Provisions (Articles 1 – 4)

1 min 05 sec

Chapter 2: Institution and Personnel (Articles 5 – 11)

Institutional and Executive Management Responsibilities

1 min 12 secs

Department Management Responsibilities

1 mins 29 secs

Personnel

1 min 02 secs

Chapter 3: Buildings and Facilities (Articles 12 – 18)

Facility Layout and Design

1 min 01 secs

Environmental Conditions and Pest Control

1 min 13 secs

Warehousing, Storage, and Inspection

1 min 33 secs

Chapter 4: Equipment (Articles 19 – 23)

Equipment: Intended Use and Operating Procedures

1 min 10 secs

Inspection and Calibration

1 min 01 secs

Chapter 5: Document Management (Articles 24 – 27)

Quality Management System Documents

1 min 23 secs

Document Control Procedures

1 min 50 secs

Record Control Procedures

1 min 06 secs

Chapter 6: Design and Development (Articles 28 – 38)

Design Control Procedures

1 min 01 secs

Design and Development Input

1 min 02 secs

Design and Development Output

1 min 10 secs

Validation

1 min 15 secs

Change Management and Risk Control

1 min 09 secs

Chapter 7: Procurement (Articles 39 – 44)

Procurement Control

1 min 11 secs

Suppliers and Procurement Requirements

1 min 33 secs

Chapter 8: Manufacturing Management (Articles 45 – 55)

Manufacturing Procedures and Quality Control

1 min 25 secs

Cleaning and Environmental Monitoring

1 min 07 secs

Manufacturing Records

1 min 31 secs

Inspection, Labeling, Traceability, and Product Protection

1 min 01 secs

Chapter 9: Quality Control (Articles 56 – 61)

Inspection Instruments and Equipment

1 min 09 secs

Product Inspection and Release Procedures

1 min 19 secs

Chapter 10: Sales and After-Sales Service (Articles 62 – 66)

Sales Records and Distribution

1 min 17 secs

Service, Installation, and Customer Feedback

1 min 37 secs

Chapter 11: Control of Nonconforming Products (Articles 67 – 70)

Control of Nonconforming Products (Articles 67 – 70)

1 min 14 secs

Chapter 12: Adverse Events Monitoring, Analysis, and Improvement (Articles 71 – 78)

Complaint Investigation and Monitoring

1 min 12 secs

Data Analysis and Corrective and Preventative Action Procedures

1 min 18 secs

Recalls and Notifications

1 min 19 secs

Internal and Management Review Procedures

1 min 20 secs

Conclusion

Final Assessment

Certification

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

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