Computerised Systems and Artificial Intelligence

Computerised Systems and Artificial IntelligenceUpdated GMPs: Revised Annex 11, New Annex 22

Expert Lecturer: Mrs. Karen Taylor (Ginsbury)

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

SKU: 25808

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The EU GMP are under major revision. The digital revolution, Artificial Intelligence and Machine Learning are here including in the pharmaceutical industry. Come and hear how regulators are addressing these hot topics and what the proposed regulations require.

Annex 11, Computerised Systems
Annex 22 (new), Artificial Intelligence

In addition, some of the proposed revisions to other sections of...Continue reading

Annex 11, Computerised Systems
Annex 22 (new), Artificial Intelligence

In addition, some of the proposed revisions to other sections of the GMPs affect computerised systems and AI as well.

Participants in the course will take away an understanding of where GMPs are heading. Every company involved in GMP / GDP activities must stay on top of these changes. See you on October 27th.

The course will address the following GMPs / Guidance documents:

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

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 is Closed

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Issues to be covered

Computerised System Definition
System Design
Design Qualification with risk management
Proactive vs Reactive:
Use of Risk-Based thinking
Governance: Documentation vs Data
Governance: Computerised Systems
Governance: Artificial Intelligence
AI: intended use
Review of the GMP drafts: 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 are updated on regulatory expectations for documentation, data, computerised systems, and controlled introduction AI/ ML use in their companies.
Participants are equipped with tools to arrange a gap analysis, some to conduct one.

About The Lecturer

Karen Taylor (Ginsbury)

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