This course covers everything an entry-level employee needs to know about CGMP (current Good Manufacturing Practice) in an API/Bulk facility. It introduces the pharmaceutical industry and its products.
It looks at the historical basis for CGMP and how industry legislation has evolved up to the present day. The 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.
Topics Covered:
- Introduction to the Pharmaceutical Industry - Introduction to GMP for APIs - Regulatory Agencies - API Contamination Prevention - Dress Codes for APIs - GMP Goals for APIs
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.
