Good Distribution Practices (GDP) – also for the Responsible Person (classroom)

2-day course on GDP guidelines and Falsified Medicines for human drugs and active ingredients (API), including changes in veterinary legislation!

Protection of the patient is the main task of wholesalers. This proven training provides an overview of the most important aspects in the GDP.

This 2-day course on GDP guidelines and Falsified Medicines for human drugs and active ingredients (API), covers current laws and regulations and what this means in practice. Special attention is given to the role of the Responsible Person/ Designated Person and recent changes in veterinary legislation.

An IGJ inspector is invited as one of the speakers.

The certificate of attendance is accepted by the Dutch regulatory authorities, in combination with relevant experience as a RP.

This course is intended for the (future) Responsible Person or Designated Person (API), Logistics manager (supervisor), Qualified Person, QA. HBO/WO level.

• Interpret and translate GDPR into practice
• Insight into "gaps" within your own organization
• GDP knowledge as required for the Responsible Person
• Know and implement the new veterinary GDP requirements

1. Recent GDP inspection experiences
2. Changes in veterinary legislation, with emphasis on GDP for veterinary.
3. GDP legislation and regulations for end products (2013/C 343/01) and active raw materials (API) (2015/C 95/01) and Falsified Medicines Directive
4. Responsibilities of the Responsible Person (end products) and Designated Person (API)
5. Supply Chain
6. Application of quality systems (incl. Change Control, Deviation Management, CAPA, Risk Management, Quality Management Review)
7. Documentation Requirements
8. Complaints, returns & recall