GMP: China Food and Drug Administration (CFDA) - GMP for Implantable Medical Devices
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Download 2024 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 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 Conclusion Final Assessment | Objectives:Skill Level: Intermediate This training program has been developed to train employees with Intermediate Knowledge of China CFDA - GMPs. | |
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