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

Description:

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.

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
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