Programs

Course Content :

1. . GMP and quality
2. GMP, cleaning, methods
3. Cleaning validation and GMP
4. Risk-based approach and risk management.
5. Acceptable criteria, product worst case, NOAEL, PDE, ADE, MACO, etc.
6. Cleaning validation sampling method, analytical methods.
7. Campaign length.
8. Issues in cleaning validation.
9. The realization.
10. Holding time
11. Protocol modules.
12. Deviation and change control