Description
KEYcademy.com – On-demand Training
In 2013, the EU requirements on Wholesale distribution and Good Distribution Practice was updated and published in Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01).
This training will give you an introduction to the requirements and a walk-through of the GDP Guide.
This training is suitable for companies with a Wholesale Dealer Authorisation both also other actors that needs to comply with GDP guidance, either party or as a whole.
Content
- Background and regulatory requirements
- The approval process and role of authorities
- Quality management and Personell
- Facilities
- Equipment
- Documentation
- Operations
- Complaints
- Outsourced activities
- Self-inspection
- Transportation
- About Brokers
Duration: 1 hour
#8020