At first glance, the idea of incorporating supplier qualification services seems appealing. However, in practice, the expected benefits often fail to materialize due to potential shortcomings in implementation. It is essential to develop a sound approach and define a clear sharing of tasks and responsibilities in advance.
Factors such as the timely integration of user requirements, structured communication, adaptation of standard qualifications, consideration of technical processes, and general procedures during critical project phases play an important role in this regard.
This topic will be explored in the technical presentation at the Lounges by Rainer Krisam, Senior Consultant at gempex GmbH:
Qualification by Suppliers: Advantages, Risks, Solutions
March 25, 2026, 4:00 p.m. to 4:30 p.m.
The lecture highlights problems in the implementation and introduces an idealized process to largely avoid them. Common misunderstandings and sources of error are systematically presented based on practical experience in GMP project management. Suggestions for a clear assignment of responsibilities between the user and the supplier regarding qualification are provided, and important milestones for defining processes in this context are presented.
The code GBPKRB is available for free participation in the event. Registration is open until March 23 on the organizer’s website.
For questions regarding “Efficient Qualification” and “Project Management in the GMP area,” please contact Rainer Krisam via contact@gempex.com.
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