What do the changes to the guideline mean for your practice?
Webcode 26112480
Dr. Cornelia Hunke
Evangelisches Krankenhaus Göttingen-Weende GERMANY
Expert in QM, ISO, and GxP standards as well as laboratory digitization Cornelia has many years of experience in industry, public service, and international research. She held a senior position at the Federal Institute for Risk Assessment (2015-2022) with responsibility for the accreditation of laboratories and NRLs. She has several years of consulting expertise as a certified auditor and lead QA in ISO, GxP compliance, and digitization in the laboratory environment. Since the end of 2025, she is a team lead for QM and risk management in hospital management at a clinic in Göttingen.
Dr. Timo Kretzschmar
ext. Consultant for INOSOLVE Consulting Service & Engineering GesmbH, Vienna, AUSTRIA
Dr Timo Kretzschmar was head of Q at a pharmaceutical analytical CRO from 2003 to 2016, from 2016-19 as inspector for GLP and computer-aided systems under GxP at AGES/BASG. From 2019-21 he was Sen. Consultant at anapur AG Vienna Region and in 2021 Q-Head GMP at Biomedical Research & Bio Products AG Vienna. From December 2021 to January 2023 he was Sen. Consultant/Project Manager for GxP/CSV (Consulting, Trainings, Audits) at Inosolve Consulting Service & Engineering GesmbH, for which he has been working as an external consultant since February 2023. Since February 2023, he has been working full-time for SCS-TECHNOLOGY Verfahrenstechnik GmbH, Linz. Dr Kretzschmar has been a part-time external lecturer at the FH Campus Wien since around 2007.
11/11/2026
11/11/2026
from 09:00 am until 01:30 pm CET - online seminar
You may dial in 30 minutes before the lecture starts
online
online
Event - 690€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Event - 690€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
EU GMP Revision: Are you prepared for the guideline changes in Chapter 4 (Documentation), Annex 11 (Computerised Systems), and Annex 22 (AI)? Receive your update - presented in a simple and understandable format - on the (expected) changes, as well as tips for practical implementation from our two experienced experts.
During this half-day seminar, experts will provide you with an overview-with relevant details presented in an easy-to-understand format-of the current draft versions of the EU GMP guidelines on Chapter 4 (Documentation), Annex 11 (Computerized Systems), and the new Annex 22 (Artificial Intelligence). You will receive recommendations for action to prepare for the planned changes at an early stage and can already start setting a strategic course for your company. After attending the seminar, you will be able to assess the expected requirements and proactively plan initial adaptation measures.
By participating in the seminar, you will gain a decisive knowledge advantage in "interpreting" the revision of the EU GMP guidelines (draft version presented). You will also save valuable time and resources thanks to the early development of implementation strategies. The half-day format can be easily integrated into your daily work routine.
09:00 Welcome, introduction, expectations
09:15
Dr Cornelia Hunke
09:45
Dr Timo Kretzschmar
11:00 Biobreak
11:15
Dr Timo Kretzschmar
12:30
Dr Cornelia Hunke
13:15
Beide Referent*innen
13:30 End of seminar
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