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E-Learning Module: Regulatory Agencies for Medical Devices
CompuPharma Ltd
This CompuPharma GMP Module is ideal for people who are new or existing employees of the Medical Device sector and who are required to work according to GMP. The Module explains who regulates the Medical Device Industry, what the role of the FDA is for medical devices, how a regulatory inspection is carried out, and the role of each employee in an inspection.
Objectives:
- Describe the difference between Pre-Market Notification and Pre-Market Approval
- Describe the purpose and work of regulatory agencies
- Explain 483 Reports and Warning Letters
- Explain the purpose of FDA inspections
- List examples of GMP violations
- List the systems typically examined in an FDA inspection
This is a self paced highly visual interactive e-Learning Module, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.
This module is extracted from the E-Learning Course: Essential GMP for Medical Device Operators (Certified)
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