Dates
- Session 1: 03-11-2026 - 09:00 - 13:00 CET
- Session 2: 10-11-2026 - 09:00 - 13:00 CET
Target audience
- Responsible Persons (or those in training to become Responsible Persons), as well as senior management professionals who are directly or indirectly involved in the storage, transport, and distribution of pharmaceutical products.
- A certain level of knowledge and experience in this field is required. Preferably, participants have previously attended our GDP - Responsible Person (English) training.
Approach
This webinar consists of two sessions that combine a theoretical overview of risk management principles and techniques with interactive exercises. Participants will have the opportunity to apply these principles in practice and collaboratively work on a warehouse temperature mapping exercise based on a practical case study.
Program
GDP and Responsible Person: Development and Responsibilities
Recent developments and key focus areas
- Updates in regulatory requirements
- Falsified medicinal products
- Practical implementation of serialization
- Responsibilities of the Responsible Person
Case study on responsibilities
Quality Risk Management (QRM)
- ICH Q9 Quality Risk Management guideline and QRM tools
- Application of QRM within GDP
- FMEA workshop
Validation and Qualification
- Validation principles
- Workshops: Warehouse temperature mapping
- Practical case studies (e.g. cold room qualification, WMS software validation)
For this training, relevant knowledge and experience are required. Preferably, participants have completed our GDP Responsible Person training.
Practical information
- Number of participants: minimum 5, maximum 20
- Start time: 09:00 AM & end time: 13:00 PM
- Video-conferencing tool: Teams
