OPS002a - CGMP: Qualifications, Equipment, and Filling Components

This course is a 2-part series of modules introducing you to Current Good Manufacturing Practices (CGMP), a set of regulations enforced by the Food and Drug Administration (FDA) that apply to the manufacturing, filling, transfilling, cascading, etc. of medical gases. This course covers the qualifications of employees and facilities, plus the proper calibration of equipment based on CGMP and looks at what takes place during the pre-fill inspection of various containers. The filling of these containers is also discussed where certain precautions and tests are conducted. Once filling is completed, retesting takes place under certain circumstances.   

Learning objectives:

1. State in general terms the CGMP regulations as applied to personnel and facilities producing medical gases; 
2. State in general terms the proper handling of medical drug gases and industrial gases; 
3. State when and how often equipment is to be cleaned and calibrated; 
4. Identify and state the appropriate pre-fill inspections for high-pressure cylinders, cryogenic home vessels, and large cryogenic vessels; 
5. State in general terms the procedures and test that take place during filling; 
6. State when retesting is to take place. 

To successfully complete this course, you must attain a minimum score of 80% on the final exam and complete the course training survey.

Continuing education: VGM Education is authorized by IACET to offer 0.1 CEUs for this program.