This course covers everything an entry-level employee needs to know about basic CGMP (current Good Manufacturing Practice) in a medical device facility. It introduces the medical device industry and its products. It looks at the historical basis for GMP and how industry legislation has evolved up to the present day.
The main industry regulatory body FDA (Food and Drug Administration) and its functions are described in detail. The specifics of following CGMP are then covered with attention to dress codes, good health and hygiene habits, and contamination prevention in a controlled environment. Also covered are the implications of CGMP non-compliance for companies, employees and consumers.
This course consists of the following modules:
- Introduction to Medical Devices - Introduction to GMP for Medical Devices - Regulatory Agencies for Medical Devices - Hygiene for Medical Devices - Dress Codes for Medical Devices - GMP Goals for Medical Devices
Certificate:
There is a 16 question assessment associated with each lesson within the Course and we offer a Certificate Service in which Users who achieve 100% in the assessment associated with each Lesson of a Course are deemed to have passed the Course, and are posted a Certificate.
