Annex 11: the new draft and its consequences - Live Online Training
4/5 September 2025
Course No. 22528
Speakers
Yves Samson
Kereon
Dr Wolfgang Schumacher
SPC – Schumacher Pharma Consult, formerly F.Hoffmann-La Roche
Michael Wegmann
Formerly F. Hoffmann-La Roche
Dr Bob McDowall
R.D. McDowall Ltd.
Frank Behnisch
Formerly CSL Behring
Dr Arno Terhechte
GMP inspectorate / Bezirksregierung Münster
All times mentioned are CEST.
Background
In an initial concept paper on the planned revision of the EU GMP guideline Annex 11 ‘Computerised Systems’ in November 2022, the planned changes and content of the new document became clear. Originally planned for the end of 2024 and expected for months, the draft revision of the EU GMP Guidance Annex 11 ‘Computerised Systems’, the draft of the completely new Annex 22 ‘Artificial Intelligence’ and the draft revision of Chapter 4 ‘Documentation’ were presented at the same time on 7 July 2025. All 3 documents can be commented on until 7 October 2025, preferably by ‘Stakeholder Organisations’ but also by anyone else.
The event will mainly focus on the draft of Annex 11 and its links to Chapter 4 ‘Documentation’. Although only a draft, the contents of the final document are clearly recognisable in the document. Therefore, in addition to a critical presentation of the document, missing topics as well as possible consequences for pharmaceutical practice will be discussed.
Target Group
The event is aimed at employees from the pharmaceutical and medical devices industry and their suppliers. It is aimed at employees who deal with current regulatory developments on IT in the European Environment.
Date & Technical Requirements
Date of the Live Online Training Tuesday, 04 September 2025, 09.00 - 18.00 h CEST Friday, 05 September 2025, 09.00 - 17.00 h CEST
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The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Programme
The Live Online Training will deal in detail with all contents of the draft Annex 11. All chapters will be dealt with according to a standardised scheme.
What are the contents of each chapter?
Which points are good, which points need to be changed / improved?
Which points are missing in the chapter?
Comparison of the requirements in the currently valid Annex 11 with the draft of the new version
What problems could arise from the new requirements for operational practice?
Chapters in the new draft of Annex 11
1./2. Introduction (Scope / Principles)
Cross-relation to Chapter 4 ‚Documentation ‘
3. Pharmaceutical Quality System
4. Risk Management
5. Personnel and Training
6. System Requirements
7. Supplier and Service Management
8. Alarms
9. Qualification and Validation
10. Handling of Data
11. Identity and Access Management
12. Audit Trails
13. Electronic Signatures
14. Periodic Review
15. Security
16. Backup
17. Archiving
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