Learning objectives
After completing the course, you will have:
- knowledge of existing rules and guidelines relating to GDP
- an understanding of how medicinal products are distributed according to GDP
Course outline
The course covers the following topics:
- Background and regulatory framework
- Requirements for wholesale authorisation
- Quality system
- GDP through the distribution chain (Certificates, Country of manufacturing and traceability, Distributor’s procedures, In the warehouse, Transport and returns, Complaints and recalls, CAPA: correct amendment procedure)
- Inspections & agreements
- Falsified medicines