Training

Designed specifically for the Qualified Person (QP) and Responsible Person (RP). This one-day training builds on your existing GDP or GMP knowledge and delves into the most important subjects of Good Distribution Practice (GDP) regulations, as a refresher. The RP is expected to train in GDP regularly, but this refresher can also be very useful for the QP who has to deal with GDP regulations. The new GDP for veterinary regulations will also be covered. In addition, we look ahead to the expected changes for 2024. This course is not suitable as a basic course.

The target group

This training course is designed for QP and RP, but also QA managers, logistics managers and those directly or indirectly involved with GDP or pharmaceutical logistics can find this course useful.

Learning Objectives

• To be aware of the development in the GDP regulations
• To know what to expect from the GDP developments in 2024
• Know your responsibilities as a QP/RP, with regards to GDP
• Understand and know the most important elements in the GDP regulations

Contents

The training takes you through the GDP guideline, from start to finish, in a compact one-day format. We discuss the most important aspects of each Chapter. This training is not intended to serve as a starting point in your career in GDP or pharmaceutical logistics/distribution. During this one-day training we discuss:

• The basics of Good Distribution Practice (GDP), the four guidelines and an update on GDP for Veterinary Products.
• The responsibilities and qualification of Personnel.
  • With a special emphasis on the Responsible Person
• Premise and Equipment, how do you handle warehouse validation for example.
• Documentation, how to properly handle documentation in the warehouse despite the dynamic environment, including Data Integrity.
• Activities, including a Workshop and recent IGJ experiences.
• Complaints, Returns, Recalls and Suspected Falsified Medicines
• Shipping Validation, including a risk assessment
• We end the day with an interactive quiz.