China Food and Drug Administration’s (CFDA’s) – GMP for Implantable Medical Devices
Description:
This course focuses on providing an understanding of the Chinese Food and Drug Administration’s (CFDA’s) Announcement on issuing an Appendix of Implantable Medical Devices to Good Manufacturing Practices for Medical Devices, 2015 Number 102. These regulations are outlined in four parts 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 31 secs |
| Learning Objectives | 1 min 21 secs |
Introduction to CFDA Appendix to GMPs for Implantable Medical Devices
| Supplementary Provisions (Part 4) | 1 min 05 sec |
| Terminology (Part 3) | 1 min 10 secs |
| Part 1: Scope and Principles | 1 min 10 secs |
| Part 2: Introduction to Special Requirements | 1 min 17 secs |
2.1 Personnel
| Education and Training | 1 min 12 secs |
| Hygiene, Health, and Clothing Requirements | 1 mins 29 secs |
2.2 Workshops and Facilities
| General Requirements | 1 min 01 secs |
| Acceptable Cleanliness Levels Part 1 | 1 min 13 secs |
| Acceptable Cleanliness Levels Part 2 | 1 min 33 secs |
| Clean Room Environment | 1 min 06 secs |
| Plumbing, Pest Control, and Other Environmental Requirements | 1 min 19 secs |
2.3 Equipment
| 2.3 Equipment | 1 min 15 secs |
2.4 Design and Development
| 2.4 Design and Development | 1 min 23 secs |
2.5 Procurement
| General Requirements | 1 min 01 secs |
| Implantable Animal-Derived Medical Devices | 1 min 02 secs |
| Implantable Allogenic Medical Devices | 1 min 10 secs |
2.6 Manufacturing Management
| General Requirements | 1 min 11 secs |
| Sterilization | 1 min 33 secs |
| Traceability | 1 min 09 secs |
| Packaging and Storage | 1 min 15 secs |
| Animal-Derived and Allogenic Medical Devices | 58 secs |
| Cleaning, Disinfection, and Pest Control | 1 min 40 secs |
2.7 Quality Control
| 2.7 Quality Control | 1 min 15 secs |
2.8 Marketing
| 2.8 Marketing | 1 min 09 secs |
2.9 Monitoring, Analysis, and Improvement of Adverse Events
| 2.9 Monitoring, Analysis, and Improvement of Adverse Events | 1 min 36 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
-
CEU Credits: 0.1 -
Course code: ELM-331 -
Duration: 60 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
If you sell medical devices to China, your personnel need to be trained on their regs. This course explains each aspect of the regs in a clear concise manner.
If you sell to the Chinese market your staff need to be trained to stay within regulatory compliance, this course is the ideal way to ensure that.
Related courses:
China Food and Drug Administration’s (CFDA’s) – GMP for Medical Devices
21 CFR Part 211 Subpart C – Building and Facilities
21 CFR Part 211 Subpart G: Packaging and Labeling Control
21 CFR Part 211 Subpart H – Holding and Distribution
21 CFR Part 211 Subpart J – Records and Reports
21 CFR Part 211 Subpart E – Control of Components, Drug Product Containers and Closures
21 CFR Part 211 Subpart D – Equipment
21 CFR Part 211 Subpart K – Returned and Salvaged Drug Products
Good Laboratory Practices: History and Regulatory Compliance
cGMP – Cases from History and the Regulations
Private: An Introduction to Good Manufacturing Practices (cGMP)
Contamination Control Strategies in a GMP Environment
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