Live Webinar Series | How to validate AI systems and survive your next inspection: under FDA and EU Annex 22 expectations

March 12, 2026

Live Webinar Series

How to validate AI systems and survive your next inspection: Under FDA and EU Annex 22 expectations

3-Part Webinar Series – Live on BigMarker – Online

This three-episode live webinar series is designed specifically for quality professionals exploring or preparing to use AI and machine learning in GxP environments. No IT background is required. You’ll learn how to critically assess risks, navigate expanding regulations, and build a risk-based quality framework for AI/ML applications.
Each episode runs for 90 minutes of focused content plus an additional 30-minute live Q&A, giving you enough time to ask your organization-specific questions.

Dates & Times

Episode 1 How to navigate regulatory guidelines for different model types and establish model credibility: Thursday, 30 April – 16:00 (Berlin time)
Episode 2 Generative AI and Explainable AI and their regulatory requirements: Tuesday, 5 May – 16:00 (Berlin time)
Episode 3 Application of a risk-based validation approach: Thursday, 7 May – 16:00 (Berlin time)

Technology & Access

Live sessions will be hosted on BigMarker (Live Mode).
Payment is processed securely via Stripe.
After registration, you’ll receive your BigMarker access links.
Recordings, handouts and gap assessment templates are included and will be shared with all paying participants.
You will also receive participation certificates.

Webinar Series Overview (3 Episodes)

Episode	Session
Episode 1: How to navigate regulatory guidelines for different model types and establish model credibility 90 min content + 30 min Q&A Dr. Ulrich Köllisch Dr. Jennifer Roebber Simge Parlar Abubakar Muhammad	Introduction to AI/ML Data integrity concepts in AI/ML Data sets and bias in models Data drift and change controls New specific regulations for AI/ML implementation Annex 22 and the EU AI act FDA guidance
Episode 2: Generative AI and Explainable AI and their regulatory requirements 90 min content + 30 min Q&A Dr. Ulrich Köllisch Dr. Jennifer Roebber	Large Language Models Unsupervised data trending Natural Language Processing (NLP) Explainable AI Meaningful and accurate explanations Black box explanations: SHAP, LIME, and CAM for single test cases and model predictions Self-interpretable models and trustworthy AI
Episode 3: Application of risk-based validation approach 90 min content + 30 min Q&A Dr. Ulrich Köllisch Dr. Jennifer Roebber	Apply the Workshop to Your Organization High Level Risk Assessment for AI/ML projects: New risk dimensions Determine model adequacy/trustworthiness Use a QA checklist to implement an AI/ML validation strategy

Episode

Session

Episode 1: How to navigate regulatory guidelines for different model types and establish model credibility
90 min content + 30 min Q&A

Dr. Ulrich Köllisch

Dr. Jennifer Roebber

Simge Parlar

Abubakar Muhammad

Introduction to AI/ML

Data integrity concepts in AI/ML
Data sets and bias in models
Data drift and change controls

New specific regulations for AI/ML implementation

Annex 22 and the EU AI act
FDA guidance

Episode 2: Generative AI and Explainable AI and their regulatory requirements
90 min content + 30 min Q&A

Dr. Ulrich Köllisch

Dr. Jennifer Roebber

Large Language Models

Unsupervised data trending
Natural Language Processing (NLP)

Explainable AI

Meaningful and accurate explanations
Black box explanations: SHAP, LIME, and CAM for single test cases and model predictions
Self-interpretable models and trustworthy AI

Episode 3: Application of risk-based validation approach
90 min content + 30 min Q&A

Dr. Ulrich Köllisch

Dr. Jennifer Roebber

Apply the Workshop to Your Organization

High Level Risk Assessment for AI/ML projects: New risk dimensions
Determine model adequacy/trustworthiness
Use a QA checklist to implement an AI/ML validation strategy

Each episode can be booked individually or as a discounted 3-session pass.

What’s Included

Access to all live sessions on BigMarker (depending on your ticket choice).
Session recordings – watch again or catch up if you miss the live session.
Handouts and practical examples for direct use in your projects.
Gap assessment templates to evaluate your current status.
Live Q&A after each episode (30 minutes) to address real-world questions.
Participation certificates.

Bonus for Early Birds

Bonus Session

All early-bird participants who register for the full 3-episode pass before 9 April will receive access to a recap session after series is complete – poll applicable participants for preferred recap topics or new topics:

+ 15 minutes Q&A – clarify any remaining questions
Delivered live, with recording available afterwards

Pricing Options

Full Series Pass (All 3 Episodes): 590€ + VAT
Best value – includes all three main sessions, recordings, handouts and templates.

Ideal if you want a complete and coherent understanding of AI/ML topics.

Book Full Series

Individual Session: 240€ + VAT per episode
Choose the session you need most.

Perfect if you are primarily responsible for a specific area or want to focus on one of the three sessions. Recording, handouts, and the gap assessment template for that episode are included.

Book Episode 1
Book Episode 2
Book Episode 3

Refund & Cancellation Policy

Full refund available if canceled before April 29, 2026.
After April 29, cancellations are non-refundable. However, you may transfer your ticket to a colleague at no additional cost.
To request a refund or transfer, please contact info@gxp-cc.com.
If GxP-CC cancels the event, you will receive a full refund of the registration fee. GxP-CC is not responsible for travel or accommodation costs.

All prices are stated in Euro and are subject to applicable VAT.

Questions?

If you have questions about the agenda, pricing, or need help with payment, please contact us at info@gxp-cc.com.

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