New VQP RP/DRP Refresher Training day course - November 26, 2025

Following a HPRA inspection, significant GDP compliance deficiencies were identified at a Dublin-based wholesaler.

  • The site lacked an appointed Responsible Person (RP) for over six months, with key RP duties, approving QMS updates, supplier qualification, and product returns performed by unqualified staff.

  • Major findings included use of unvalidated cold-chain transport systems, incomplete deviation management, inadequate supplier bona fides, and poor oversight of outsourced transport providers.

  • This contract RP assignment focuses on restoring GDP compliance through CAPA implementation, validation of temperature-controlled systems, reinstatement of RP governance, procedural revision, and requalification of suppliers, ensuring full regulatory alignment and patient safety.

  • Are you up to the task as the newly onboarded contract RP??

    Who is this course for?

    For companies with staff involved in:

  • WDA activities e.g. QA/SC/Ops/RP/DRPs

  • Working for companies with Virtual (i.e. Financial Procure and Supply) or site based WDAs

  • Looking for a NEW, practical, 1 day refresher RP/DRP/GDP Training in 2025 (not the same slides by chapter for the past 10 years)

  • With Training materials based on recent HPRA inspection trends and industry case studies

Secure Your Spot

Upcoming Training at NIBRT - Q1 2026

In Q1 2026, Dr. Kieran Fitzgerald from VQP, will deliver an industry best practice course on Good Distribution Practice (GDP) at NIBRT, Ireland’s world-class biopharma training institute.

Modern office building with glass windows, surrounded by a lawn and trees, with two people talking outdoors.

Good Distribution Practice: A Practical Perspective

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).

The Responsible Person (RP) plays a critical role in overseeing the ever-evolving complex global supply chains ensuring that their respective companies medicinal products are transported, stored and delivered in compliance with GDP, and the conditions of the respective companies (WDA) are strictly adhered to.  

This 2 day in person training course at NIBRT, Dublin is specifically designed as a “hands on” practical guide (through a series of RP led practical on-site workshops) to equip all personnel involved in GDP operations with the practical skills for HPRA inspection readiness. Participants will gain a comprehensive understanding of the GDP inspection process and best practices for inspection preparation employing a simulated Mock HPRA inspection.   The course material covers the latest HPRA Inspection trends and guidance updates, providing trainees with an industry best practice GDP self-assessment checklist to proactively manage their GDP compliance post course completion.

  • Day 1 is focussed on Warehouse activities (Product Storage/Facility Layout and Equipment Qualification) including a GDP Facility Site Tour in the afternoon

    • Workshop: Designing a GDP-Compliant Warehouse Layout (NIBRT on site)

  • Day 2 is focussed on Transport solutions (Shipping validation and Global supply chains) and will include a transport solution provider exhibit in the afternoon

    • Workshop: Mock HPRA Inspection (NIBRT on site)

Learn more about the course and book your spot at NIBRT at the link below.

https://www.nibrt.ie/product/good-distribution-practice-a-practical-perspective/#register-for-corse

Secure Your Spot