Validating AI in GxP – What You Need to Know Now
July 11 Webinar: Regulatory Expectations & Practical Insights
Artificial Intelligence (AI) is no longer a futuristic concept—it is already transforming businesses across various industries, including highly regulated sectors like pharmaceuticals and medical technology. The potential is enormous: automation, increased efficiency, and data-driven decision-making. But as technology advances, so do regulatory challenges.
In the strictly regulated GxP environment, there is often a lack of clear guidelines for validating AI systems. Traditional CSV approaches reach their limits, as AI operates in a data-driven, dynamic, and often non-deterministic manner. What does this mean for compliance, auditability, and risk analysis? And how can AI be handled in a traceable, risk-based way in systems that require validation?
In the third and final part of our webinar series on modern IT validation, we address the opportunities and challenges of AI applications in regulated environments. Our expert Cecilia Vallet will provide a practical overview, highlight regulatory requirements, and explain how AI solutions can be validated in a structured and risk-based manner.
What you will learn:
- Current developments in the use of AI in regulated industries
- Unique challenges of validating AI/ML systems
- Differences from traditional CSV: where new approaches are needed
- Dealing with the lack of regulatory guidance
- Governance models, risk assessments, and data integrity in AI applications
Date: Friday, July 11, 2025
Time: 11:30 AM
Duration: approx. 35 minutes
Speaker: Cecilia Vallet, Senior Consultant, Thescon GmbH
This webinar is part of our three-part series on key IT validation topics:
- Validating in Modern IT Environments
- Cloud Validation in Regulated Industries
- Validating AI & Machine Learning – Requirements and Practice (this webinar)
Register now and receive your personal access link by email.
For more information about our services and references, please visit: www.thescon.de
Our webinars are free of charge and intended for customers and interested parties of Thescon GmbH. Service providers and consultants are excluded from participation.
We are looking forward to your participation!