The ISPE GAMP® 5 Guide (Second Edition) was published on 29 July 2022. It was presented and discussed at the 2023 ISPE Europe Annual Conference, the 2023 ISPE Annual Meeting & Expo, and at several local...
The importance of the 2024 ISPE Europe Annual Conference is evident with the continuous challenges the pharmaceutical industry is facing in terms of drug shortages, regulatory requirements, digitalization, automation, and big data management.
It is an exciting time in life sciences. Many companies have focused initial artificial intelligence/machine learning (AI/ML) adoption efforts on developing and implementing ML trained algorithms, which necessitate following a controlled approach such as the GAMP® 5 ML Sub-System methodology shown below. This blog highlights key artifacts and considerations when implementing AI/ML for GxP use...
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Live-streamed education sessions.
At the 2023 ISPE Pharma 4.0™ and Annex 1 Conference, held 11 – 12 December 2023 in Barcelona, Spain, a panel discussion that included regulators from around the world, as well as industry experts,...
Carla J. Lundi, US Food and Drug Administration (FDA) Senior Consumer Safety Officer, Division of Quality Intelligence II, FDA, presented the regulatory keynote at the 2024 ISPE Facilities of the Future...
