Good Distribution Practice: A Practical Perspective
Overview
Marketing Authorization holders, Manufacturers and all stakeholders in their respective product supply chains (e.g. wholesalers, warehouses, hubs, depots, transport and logistics service providers) must ensure their medicinal products are distributed under controlled conditions as laid down in the European Guideline (2013/C 343/01).
This 2 day in person training course at NIBRT, Dublin is specifically designed as an introductory hands-on practical guide for new warehouse/site-based personnel (through a series of instructor led practical on-site workshops) looking for practical training in GDP operations.
The course covers the following EU GDP chapters 3/5, Premises & Equipment, Operations and Transport.
- Day 1 is focussed on Warehouse activities (Product Storage/Facility Layout and Equipment Qualification) including a “live” GDP Facility Site Tour in the afternoon
-
- Day 1 Workshop: Designing a GDP-Compliant Warehouse Layout (NIBRT on site)
- Day 2 is focussed on GDP Transport solutions (Shipping validation and Global supply chains) and will include a transport solution provider exhibit in the afternoon
-
- Day 2 Workshop: Mock HPRA Warehouse Inspection (NIBRT on site)
Key topics covered
- EU GDP Guidelines (2013/C 343/01) – Scope, Roles and Responsibilities
- HPRA Focus and most common GDP Audit Observations
- GDP Compliant Warehouse Operations
- Storage Qualification and Environmental Controls
- GDP in Transport – Cold Chain and Documentation
Who should attend
- Staff training in wholesaling of medicinal products or distribution operations
- Applicant DRPs looking for a practical GDP course
- GDP Logistics and Distribution/Warehouse Managers/Supervisors looking to strengthen their practical knowledge of the current EU GDP Guidelines and legislation
- Operations/QA/Supply Chain personnel (site based) looking for practical GDP training
- Site based Pharma companies looking for practical GDP training for their Quality/Supply Chain operations staff as a precursor to DRP applications to HPRA
- Warehouse supervisors/managers or personnel who are new to GDP operations
- GDP Auditors learning how to inspect GDP/GMDP storage facilities
- Quality and Warehouse Managers at Transport and logistics service providers
Register
Course Format
Onsite Training at NIBRT
- 2 full days onsite training at NIBRT facility
Dates & Price
Dates:
- Course 1 26/03/2026 - 27/03/2026€2,150.00
16 Places Remaining
