In this course, the student will learn the basic regulatory requirements for the manufacturing and control of pharmaceutical drugs and devices. We discuss topics such as:
- Where and when regulations apply
- Basic philosphy of cGMP
- Regulatory bodies
- cGMP regulations - FDA, EU and ICH
- The Barr Laboratories case
- Pharmacopoeias
- Regulatory inspections
- The quality control unit
- Standard operating procedures (SOP)
- Documentation
- Training
- Change control
- Validation
- Individual responsibilities
Tthe course allows for plenty of discussion and questions.