MASTER DI ALTA SPECIALIZZAZIONE:
Parte 1: Good Manufacturer Practises: definition and field of application.
- Storia delle GMP: requisiti e aggiornamenti normativi
- Process Mapping: il ruolo della QP
- Change Management
Parte 2: Data integrity & pharmaceutical companies approach.
- Data integrity: applicational requirements
- Impact Evaluation on internal processes
- Batch Record Review & OSS