Who will the course benefit?
This GDP course is aimed principally at personnel new to working with GDP as well as those needing an update on more recent changes in GDP requirements and expectations. The course is also of great value to anyone who is, or wishes to be, a Responsible Person (RP). In addition the course will provide those used to working with Good Manufacturing Practice (GMP) an insight into the principle similarities and differences between GDP and GMP.Course overview:
Delegates will learn about GDP and how it is applied during warehousing and transportation of pharmaceutical products. Delegates will leave the course with a clear understanding of the requirements of EU GDP and how it is usedFor a more in-depth course our unique 3-day Responsible Person course may be of interest
A short online refresher/compliance programme costing from £95 per delegate is also available - for more details see our website
Course contents:
- An introduction to GDP
- The similarities and differences between GMP and GDP
- Why do we have GMP and GDP in pharmaceuticals?
- Licences for medicines and enforcement
- The legal status of GDP
- The structure of the EU Guide to GDP
- Current and future issues in GMP
- The Falsified Medicines Directive (an overview)
- Duties of Management and the Responsible Person
- The principle GMP requirements for documentation and records
- GDP in the warehouse
- GDP during transportation
- The recall mechanism
