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Pharma Testing Day

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Ensuring GxP Data Integrity – a True Mission Impossible?


Data integrity has already been an inherent, not specifically highlighted core element of all GxP regulations for decades. However, due to significant violations coming up increasingly with the breathtakingly fast development of modern computerized systems, regulatory authorities worldwide— including the FDA and European agencies (EMA)—have intensified their focus. Annex 11, along with FDA guidelines, sets strict requirements for electronic records and data integrity from the premise to the cloud using classical apps up to AI. 
Since 2015, additional new guidelines from MHRA, WHO, PIC/S and OECD/GLP as well as EMA electronic data in clinical trials guideline seem to clarify expectations by taking partially different ways.
However, different manifestations of the same topic carry as “the other side of the coin” the risk of misinterpretation and proliferation, like “too many cooks spoil the broth”. These “side effects” should be considered and minimized as soon as possible.


Join our seminar to gain essential insights into current requirements and best practices for implementing a robust data integrity system – avoiding hidden and almost irresistible pitfalls.

Dr. Timo G. Kretzschmar will give a lecture on: How Cloud and AI Are Shaking Up Data Integrity, Annex 11, and Regulatory Compliance
 

Georg Roth-Kapori, Dr. Timo G. Kretzschmar (Lingua: English)

Gruppo di destinazione: Parties from the pharmaceutical, medical, and cosmetics sectors

Programma:

Luogo: Graz, Österreich, Anton Paar GmbH Graz
Organizzatore: Anton Paar Austria
Fine della registrazione: 24 mar 2025

Persona di riferimento e registrazione:
Gabriele Pflanzl
Tel.: +43 - 316 - 269571 - 203
gabriele.pflanzl[at]anton-paar.com

Georg Roth-Kapori

Georg Roth-Kapori is part of the Global Pharma Team at Anton Paar. He holds a master degree in organic chemistry and food development and has more than 20 years of experience in food and pharmaceutical industry standards and regulations. For the past 10 years, he has been responsible for pharmaceutical requirements, instrument qualification documentation, and training at Anton Paar for regulated markets. Furthermore, he is a keynote speaker for Data Integrity, ALCOA++, cGMP, GAMP5 at Concept Heidelberg.

Timo G. Kretzschmar

Timo Kretschmar holds a doctorate in technical chemistry (1986-91 TH Leuna-Merseburg, 1991-93 TU Graz). First working at TÜV Austria (1993-1998) and freelance (1999-2001) in the area of environmental protection technology / risk prevention as well as in the measurement technology area at Thermo Electron (2001-03), he moved to CRO pharm-analyt Labor GmbH (Baden/Vienna) as Quality Manager from 2003 to 2016, where he became hands-on with GxP and CSV. In 2016, Timo went to the pharmaceutical authority AGES/BASG as an inspector for GLP and computerised systems / data integrity for 3 years. Since 2019, Timo has been working as a consultant for GxP, specifically GLP, GMP and computerized systems / data integrity (anapur AG, Inosolve Consulting Service & Engineering GesmbH, partly self-employed “TiKrESolution” since 2023), between (6 months in 2021) as Head of QM/GMP at Biomedical Research & Bio Products AG Vienna. 2023 he started as project manager in chemical / process engineering at SCS-TECHNOLGY GmbH Linz and since September 2024 he started again part-time as a Q manager at pharm-analyt Labor GmbH. Timo is also a lecturer at technical colleges / universities of applied sciences and a frequent speaker at appropriate seminars and trainings.