AI, Documentation, Data Integrity and Computerised Systems - New Annex 22; Revised Annex 11 and Chapter 4

AI, Documentation, Data Integrity and Computerised Systems – New Annex 22; Revised Annex 11 and Chapter 4Interactive Workshop

Expert Lecturer: Mrs. Karen Taylor (Ginsbury)

Categories: Clinical Data Management, IT - Information Technology, Laboratory, Quality

SKU: 25808

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EU GMPs are under revision. This course will look at proposed revisions to: Chapter 4, Documentation, Annex 11, Computerised Systems and the new Annex 22 on Artificial Intelligence. A quick look at the revisions to Chapter 1, the Pharmaceutical Quality System will allow a holistic understanding of...Continue reading

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The course will address the following GMPs / Guidance documents:

Regulatory Agency	Document Title	Issue Date	Status
EU	Annex 22 Artificial Intelligence	07/07/25	Draft
EU	Chapter 4 Documentation (relevant parts)	07/07/25	Draft
EU	Annex 11 Computerised Systems (relevant parts)	07/07/25	Draft
EU	Chapter 1 Pharmaceutical Quality System	03/09/25	Draft
FDA	Guidance for Industry Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products	Jan 2025	Draft
EMA	Reflection Paper Use of AI in the Medicinal Product Lifecycle	Sept 2024	Final
FDA	Discussion Paper Artificial Intelligence in Drug Manufacturing	2023	Final

See you on October 27^th.

Course Instructor

This course will be presented Karen Taylor (Ginsbury).

Karen has over 30 years’ experience of quality systems in the pharmaceutical industry.

As a past member of PDA’s Regulatory Affairs and Quality Advisory Board, Karen Ginsbury was actively involved in commenting groups on EU, US and worldwide changes to GMPs and guidances as well as interpretation.

This course is an opportunity to learn from her perspective, regarding what is happening as globalization affects industry’s ability to stay updated.

Date: 27 October, 2025

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Course location: Hybrid: Virtual & Scientific Park Nes Tziona Kiryat Weizmann

Duration: 1-Day Course

Hours: 09:00 - 17:00

Credits: 1

Course Language: עברית

Course price: 2,550 NIS + VAT

Early registration discount until October 19, 2025:
2290 NIS + VAT.

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Issues to be covered

The course will discuss:
– Proactive vs Reactive: Use of Risk-Based thinking in managing the Quality System
– Governance: Documentation vs Data
– Governance: Computerised Systems
– Governance: Artificial Intelligence
– Review of the GMP drafts: Documentation, Computerised Systems, Artificial Intelligence
– How to get ready: which elements are here to stay
– Gap analysis

Who should attend

This course is suitable for:

Anyone working in the pharmaceutical industry including Company General Managers, Managing Directors, QPs, Quality Assurance, Quality Control and other quality professionals, Operations Managers, Production Managers, Research and Development, persons working in technology transfer, personnel working in pharmaceutical Active Substance and finished product manufacture. Persons involved in clinical trials and manufacture and administration of Investigational Medicinal Products will also find the course useful.

Benefits to the Participants

At the end of this course participants will be up to date on regulatory expectations for documentation, data, computerised systems, and controlled introduction AI/ ML use in their companies. Participants will be able to arrange for a gap analysis, some to conduct one.

About The Lecturer

Karen Taylor (Ginsbury)

Karen Ginsbury, CEO of PCI Pharmaceutical Consulting Israel Ltd. Karen