Beyond Compliance: AI in GxP – Identifying Opportunities, Minimizing Risks – Webinar Invitation

Discover the opportunities and challenges of using and validating AI applications in the GxP environment.


The use of artificial intelligence (AI) promises the prospect of new, potentially revolutionary business models and innovative approaches to make processes faster and more efficient.

However, particularly in the strictly regulated GxP environment, the risks of AI applications must also be taken into account. We want to help you understand the background and arm yourself for discussions on this topic.

Our expert and Senior Consultant Cecilia Vallet will give you an insight into the challenges of using and validating AI applications.

The hurdles in validating AI applications are (still) numerous: on the one hand, there are no regulatory guidelines specifically adapted for AI models. Furthermore, the validation activities established for conventional programs are not necessarily fully applicable to AI programs. These concerns may stand in the way of an unreserved engagement with the topic of AI, but they will not and should not stop the development and the demand.

Some tried and tested basic principles of conventional CSV (especially in the area of testing and data management) cannot be scaled or adopted without restrictions.

In order to use AI applications in a regulated environment, dealing with the subject is important not only within a company, but also in dialogue with suppliers, customers, and authorities. AI-specific aspects must be taken into account in the guidelines for the development and control of AI models. A clearly defined purpose of use (‘intended use’), a comprehensive risk analysis, and special requirements for data management are, in our estimation, essential foundations for the use of AI in regulated areas.

Thescon is characterized by years of experience and industry-specific expertise in the regulated industry and is your independent industry expert in the field of CSV and the requirements for artificial intelligence. In our free webinar, we offer you an overview of the most significant challenges of this topic.

Here are the details:

Topic: Beyond Compliance: AI in the GxP sector – Recognizing opportunities, minimizing risks

Date: 08/31/2023

Time: 10.00 AM

Duration: 45 minutes

Let us know via the contact form how we can send you your very personal invitation link. You will then receive an invitation with the access data for the free webinar.

We are looking forward to your participation!

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