Risk Management in the Pharmaceutical Industry

In pharmaceutical manufacturing of medicines, deviations in production can cause significant damage. Therefore, it is important to understand the process in order to identify potential hazards early and implement preventive measures.

We will show you how to integrate and maintain a robust and efficient quality risk management within your quality management system. How to best handle changes, deviations, OOS (Out of Specification), and CAPAs (Corrective and Preventive Actions). And how to foster a quality culture.

Furthermore, we will explain which tools are commonly used for risk assessment, where their strengths and weaknesses lie. We will give you tips on their application. However, if a holistic approach is not applied, it might happen that a source of error is not identified. This approach is pursued by the new Annex 1 with its contamination control strategy. Learn how this approach is competently implemented.

But enough theory—this afternoon, you will become active! In the workshop, you will work in groups on concrete case examples to develop the appropriate risk management. We will show you what effort is justified according to the scope.

Supervised by our experts, we support you with our experience and expertise. Discuss the advantages and disadvantages with us; we are happy to advise you.