GMP: China Food and Drug Administration (CFDA) - GMP for Medical Devices
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Download Saturday, May 16, 2026 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
.
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Free Trial CoursesOutline:Introduction Overview Who Should Take This Course? Learning Objectives Definitions Introduction to CFDA GMPs for Medical Devices Supplementary Provisions (Chapter 13, Articles 79 - 84) Chapter 1: General Provisions (Articles 1 - 4) General Provisions (Articles 1 - 4) Chapter 2: Institution and Personnel (Articles 5 - 11) Institutional and Executive Management Responsibilities Department Management Responsibilities Personnel Chapter 3: Buildings and Facilities (Articles 12 - 18) Facility Layout and Design Environmental Conditions and Pest Control Warehousing, Storage, and Inspection Chapter 4: Equipment (Articles 19 - 23) Equipment: Intended Use and Operating Procedures Inspection and Calibration Chapter 5: Document Management (Articles 24 - 27) Quality Management System Documents Document Control Procedures Record Control Procedures Chapter 6: Design and Development (Articles 28 - 38) Design Control Procedures Design and Development Input Design and Development Output Validation Change Management and Risk Control Chapter 7: Procurement (Articles 39 - 44) Procurement Control Suppliers and Procurement Requirements Chapter 8: Manufacturing Management (Articles 45 - 55) Manufacturing Procedures and Quality Control Cleaning and Environmental Monitoring Manufacturing Records Inspection, Labeling, Traceability, and Product Protection Chapter 9: Quality Control (Articles 56 - 61) Inspection Instruments and Equipment Product Inspection and Release Procedures Chapter 10: Sales and After-Sales Service (Articles 62 - 66) Chapter 11: Control of Nonconforming Products (Articles 67 - 70) Chapter 12: Adverse Events Monitoring, Analysis, and Improvement (Articles 71 - 78) | Objectives:Skill Level: Intermediate This training program has been developed to train employees with Intermediate Knowledge of China CFDA - GMPs. | |
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