Overview
This focused half-day event brings together professionals from Quality Assurance, Supply Chain, and Logistics to explore the evolving landscape of Good Distribution Practice (GDP) and its critical role in managing change and ensuring compliance across complex pharmaceutical supply chains.
Participants will gain practical insights into mapping product flows, managing supply chain changes, and auditing global logistics partners—especially those operating outside the EU.
The event will also address key compliance challenges identified in recent inspections, including knowledge management gaps and oversight of Responsible Persons (RPs).
Key Sessions & Topics
Mapping Product Flows & Supply Chain Mapping
Case study how to trace product movement from API manufacturing to final release, including packaging and logistics.
Panel Discussion: Change Management in Supply Chain (GDP Perspective)
Define what constitutes a change in the supply chain and how to manage it effectively. Explore regulatory expectations and real-world examples.
Risk Assessments for Cold Chain Routes – Case Study
Apply risk assessment principles to cold chain logistics. Learn how deeper mapping and scenario planning (e.g., flight delays, cold box failures) enhance preparedness.
Customer Validation & Quality Agreements
Explore best practices for validating customers and managing technical agreements to ensure compliance and performance.
Auditing & Managing 3PLs Outside the EU
Navigate the complexities of working with international logistics providers, with a focus on GDP oversight and regulatory expectations.
For more information, please contact: siobhan.dean@ibec.ie