Pharma Testing Day

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
 

分野: Parties from the pharmaceutical, medical, and cosmetics sectors

会場: Graz, Österreich, Anton Paar GmbH Graz
主催者: Anton Paar Austria
登録締切日: 2025/03/24

連絡先及び登録:
Gabriele Pflanzl
電話番号: +43 - 316 - 269571 - 203
gabriele.pflanzl[at]anton-paar.com