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

Overview
Who Should Take This Course?
Learning Objectives
Definitions
Introduction to CFDA GMPs for Medical Devices
Supplementary Provisions (Chapter 13, Articles 79 – 84)
General Provisions (Articles 1 – 4)
Institutional and Executive Management Responsibilities
Department Management Responsibilities
Personnel
Facility Layout and Design
Environmental Conditions and Pest Control
Warehousing, Storage, and Inspection
Equipment: Intended Use and Operating Procedures
Inspection and Calibration
Quality Management System Documents
Document Control Procedures
Record Control Procedures
Design Control Procedures
Design and Development Input
Design and Development Output
Validation
Change Management and Risk Control
Procurement Control
Suppliers and Procurement Requirements
Manufacturing Procedures and Quality Control
Cleaning and Environmental Monitoring
Manufacturing Records
Inspection, Labeling, Traceability, and Product Protection
Inspection Instruments and Equipment
Product Inspection and Release Procedures
Sales Records and Distribution
Service, Installation, and Customer Feedback
Control of Nonconforming Products (Articles 67 – 70)
Complaint Investigation and Monitoring
Data Analysis and Corrective and Preventative Action Procedures
Recalls and Notifications
Internal and Management Review Procedures

Conclusion

Final Assessment

Certification

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

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