AI in the GxP Environment:
What Regulatory Requirements Exist, and What Does This Mean in Practical Terms for Validation?
Artificial intelligence is increasingly finding its way into quality assurance, production, and documentation at pharmaceutical and medical device companies. Any AI-based solution that affects product quality, patient safety, or the integrity of GxP-relevant data must be validated.
The key question, therefore, is not “if,” but “how.”
In this webinar, we’ll provide context on current regulatory expectations, particularly the EU AI Act and Draft Annex 22. We’ll also highlight the guidance offered by the ISPE GAMP® AI Guide. Following that, we’ll provide practical insights into how AI solutions can be validated: from risk-based classification and governance to integration into the V-model and the necessary adjustments throughout the entire lifecycle.
Date
Thursday, November 19, 2026, 10:00 a.m. to 10:45 a.m.
Can’t make it on this date? Register anyway and receive a recording of the webinar afterward.
Webinar Content
- Regulatory framework: AI Regulation, EU GMP Annex 22 (draft), as well as FDA and EMA publications and classification according to the ISPE GAMP AI Guide
- Risk assessment of AI-supported systems and joint consideration of criticality according to GxP and the AI Regulation
- Discussion on the use of non-deterministic AI in regulated operations
- Comparison of the validation of traditional systems and AI-supported systems, and the relevance of data
- Practical process model for AI validation: An extended V-model
Target Audience
This webinar is intended for professionals and decision-makers in the pharmaceutical, medical device, biotechnology, and other regulated industries who are implementing, validating, or operating AI-supported systems.
The event is particularly relevant for:
- CSV and validation experts
- Quality and compliance managers
- Data scientists and data officers in GxP environments
- IT Directors and Digital Transformation Leaders
- Test, Release, and Change Managers
- Audit and Regulatory Affairs Managers
Benefits for You
- You’ll gain an overview of the most important AI regulatory frameworks and their current status (in effect, guideline, or draft).
- You’ll learn about key prerequisites for deployment in a regulated environment.
- You’ll understand which decisions should be made prior to implementation.
- You’ll gain guidance on the DHC scoping packages, ranging from Cloud ALM Scope to Target Design.
Registration and Participation
Our web sessions are a free service for DHC customers and prospects.
IT service providers and consultants are excluded from participation.
The number of participants is limited.