AI in the GMP environment – a topic that is currently developing rapidly and being discussed with great interest. What are the possible applications? Can efficiency be improved by using artificial intelligence to achieve compliance? Can AI actually facilitate compliance with GMP regulations?
A seminar by Concept-Heidelberg on September 24, 2025, is dedicated to this topic:
The Use of Artificial Intelligence in Qualification and Validation.
On September 16, 2025, the seminar will also be held in German language „Der Einsatz von Künstlicher Intelligenz bei der Qualifizierung und Validierung“.
From the perspective of a GMP inspector, fundamental terms will be explained, EU framework conditions such as the pharmaceutical quality system according to ICH Q10, data governance, data integrity, and GAMP 5 will be presented in an overview, specific requirements from Annex 11 or the draft of Annex 22 will be discussed, with a focus on the topic of testing.
Ralf Gengenbach, Managing Director of gempex GmbH, will speak at the event from the perspective of an industry representative in a presentation entitled "The Use of Artificial Intelligence in Equipment Qualification and Process Validation."
Based on the fundamentals of qualification and validation, a basic understanding of AI and its reliable application will be provided, and various AI models and possible uses will be presented. Concrete examples from practice will be used to illustrate the tasks for which the use of AI is suitable, as well as the limitations that arise when using AI in a GMP-regulated environment.
A case study will give participants the opportunity to engage in practical exercises. The presentation will conclude with a cost-benefit analysis.
More information about the event and registration details are available on the organizer's website Concept Heidelberg (gmp-navigator.com, Seminar No. 22271).
If you have any questions on the topic AI and GMP, please contact gempex via contact@gempex.com.
This may also interest you:
GMP Consultancy