Live Webinar Series | Applying EU GMP Chapter 4, Annex 11 & Annex 22

December 17, 2025

Live Webinar Series

Applying EU GMP Chapter 4, Annex 11 & Annex 22 From requirements to practical implementation in GxP environments

3-Part Webinar Series – Live on BigMarker – Online

This three-episode live webinar series is designed for QA, QC, and IT/CSV professionals working in GxP environments who need a practical and risk-based understanding of the new EU GMP Drafts of Chapter 4, Annex 11, and Annex 22. 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 (EU GMP Chapter 4): Thursday, 29 January – 16:00 (Berlin time)
Episode 2 (Annex 11): Tuesday, 3 February – 16:00 (Berlin time)
Episode 3 (Annex 22): Thursday, 5 February – 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: EU GMP Chapter 4 90 min content + 30 min Q&A Dr. Ulrich Köllisch James Francum	Most significant changes between current Chapter 4 and the new draft and a deep dive into documentation, records, and data governance requirements under Chapter 4. Data Governance Controlling and maintaining critical GxP records (paper and electronic) Hybrid systems Interplay Chapter 4 and Annex 11: Data and documentation, computerized systems and electronic data
Episode 2: Annex 11 90 min content + 30 min Q&A Dr. Ulrich Köllisch Dr. Sangeetha Venkataraman	Most significant changes between current Annex 11 and the new draft guideline. Practical application of Annex 11 for computerized systems in regulated environments. Structure and principles of the new draft Third party management as a focus point Security as a new chapter Audit trail and audit trail reviews Preparation for implementation
Episode 3: Annex 22 90 min content + 30 min Q&A Dr. Ulrich Köllisch Dr. Jennifer Roebber	Understanding and implementing Annex 22 expectations in practice. Scope: deterministic vs probabilistic; static vs dynamic models Testing: The main inspection focus? Supplier and service provider oversight Inspection readiness Comparison with other AI/ML guidelines

Episode

Session

Episode 1: EU GMP Chapter 4
90 min content + 30 min Q&A

Dr. Ulrich Köllisch

James Francum

Most significant changes between current Chapter 4 and the new draft and a deep dive into documentation, records, and data governance requirements under Chapter 4.

Data Governance
Controlling and maintaining critical GxP records (paper and electronic)
Hybrid systems
Interplay Chapter 4 and Annex 11: Data and documentation, computerized systems and electronic data

Episode 2: Annex 11
90 min content + 30 min Q&A

Dr. Ulrich Köllisch

Dr. Sangeetha Venkataraman

Most significant changes between current Annex 11 and the new draft guideline. Practical application of Annex 11 for computerized systems in regulated environments.

Structure and principles of the new draft
Third party management as a focus point
Security as a new chapter
Audit trail and audit trail reviews
Preparation for implementation

Episode 3: Annex 22
90 min content + 30 min Q&A

Dr. Ulrich Köllisch

Dr. Jennifer Roebber

Understanding and implementing Annex 22 expectations in practice.

Scope: deterministic vs probabilistic; static vs dynamic models
Testing: The main inspection focus?
Supplier and service provider oversight
Inspection readiness
Comparison with other AI/ML guidelines

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 against Chapter 4, Annex 11, and Annex 22.
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 12 January will receive access to a dedicated revision session on Chapter 1:

Chapter 1 Revision: 30 minutes of focused recap
+ 15 minutes Q&A – clarify any remaining questions
Delivered live, with recording available afterwards

Early bird registrations for the the full series has closed.

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 Chapter 4, Annex 11, and Annex 22, and how they fit together in a risk-based compliance framework.

Book Full Series

Individual Session: 240€ + VAT per episode
Chapter 4, Annex 11, or Annex 22 – choose the one you need most.

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

Book Chapter 4
Book Annex 11
Book Annex 22

Refund & Cancellation Policy

Full refund available if canceled before January 28, 2026.
After January 28, 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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