GMP Compliance in Focus

This practical-oriented seminar provides a comprehensive overview of key GMP topics with a focus on CAPA, deviation management, inspections, change control, and GMP documentation. The goal is to implement regulatory requirements confidently and to pass inspections with ease. You will learn how to define CAPAs in a cause-based and sustainable manner and how to reliably demonstrate their effectiveness. In the area of Deviation & Investigation, the emphasis is on structured deviation management and systematic root cause analysis. Another focus is on preparing for and conducting inspections:

How can processes, data, and staff remain audit-ready on a permanent basis? How does one communicate clearly, factually, and consistently with inspectors? These topics are deepened in an interactive workshop on inspection behavior, where typical situations are trained in a realistic manner. The seminar is rounded off with change control involving risk-based assessment of changes, as well as an overview of current requirements for GMP documentation, including the updates in EU-GMP Chapter 4 with particular attention to data integrity (ALCOA++).