Risk Assessment In Pharmaceutical Supply Chain As Basic Tool In GDP And Backbone For Transport Process Validation Workshop

Risk Assessment In Pharmaceutical Supply Chain As Basic Tool In GDP And Backbone For Transport Process Validation Workshop

• Importance of risk assessment in GDP
• Legal requirements and risk-based approach
• Transport process validation
• Intersection of risk assessment, regulatory compliance, and collaboration
• Roles and responsibilities

This workshop will go through risk assessment /risk analyses (ICH Q9) as the basic tool and principle of GDP and why the cooperation of all parties involved is essential. Why is that so important? All legal requirements in good distribution practice (GDP) do refer to a so-called “risk-based approach” – regardless of the means of transport.

To fulfill these requirements, the client/sender (pharmaceutical company) is obligated to do a transport process validation. The basis for this transport process validation is a proper risk assessment!

The workshop will show the big picture of the pharmaceutical supply chain and delve into the intersection of risk assessment, regulatory compliance, responsibilities, and different collaboration – especially in airfreight. By using practical examples and through discussions, attendees will gain insights into the ostensible differences and similarities between airfreight contracts and GDP regulations. Additionally, it outlines the roles & responsibilities of the clients (pharmaceutical companies), the shippers (shipping agents), and the forwarders (airlines).

Bernhard Zoidl, Independent consulter and trainer in the pharmaceutical area

Speakers