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Shaping the regulated quality of tomorrow.
Articles and analysis from our own work across GxP, pharma, quality management, GAMP and AI - what is changing in the regulated environment, what it means in practice, and what is happening inside our company.
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Article by QFINITY’s Senior Executive Consultant ranks 3rd most read article in Clinical Supplier Leader
We are pleased to announce that Frank Henrichmann’s article was the third most-read article on the Clinical Supplier Leader platform in October. The topic of the article was ‘Massive Data, More Decentralisation Drive Updates To ISPE GAMP Guide’. This underscores the article’s relevance to the clinical research and development community.
The article highlights the need for a new version of the ISPE GAMP Guide. Mr. Henrichmann addresses the far-reaching changes in the clinical data landscape. He focuses on risk-based system validations under Good Clinical Practice. He offers insights and recommendations to help clinical trial stakeholders overcome new challenges and make the most of modern data architectures.
At QFINITY, we see the strong response to Mr. Henrichmann’s article as confirmation of how much pharmaceutical and clinical research depend on current, practical information. It also shows how much the dialogue about innovative, decentralized data systems and adapting to new regulatory requirements matters.
Congratulations to Frank Henrichmann on this recognition of his work, which gives the industry valuable food for thought!
You can find the full interview here. More information on the Clinical Supply Leader placement is available here.
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Read the article at Clinical Leader (clinicalleader.com)↗
ISPE GAMP Southasia Webinar with Senior Executive Consultant from QFINITY | November 28, 2024
Frank Henrichmann is Senior Executive Consultant at QFINITY, co-leader of the second edition of the ISPE GAMP Good Practice Guide on Validation and Compliance of Computerized GCP Systems and Data and co-chair of the GAMP Global Steering Committee.
The webinar will be held on November 28th at 9am PKT and will run for 60 minutes.
His presentation will cover:
The South Asia webinar is free of charge, but you need to register in advance at https://tinyurl.com/GAMPGCP.
We look forward to seeing you there.
QFINITY’s Senior Executive Consultant at the ISPE Annual Meeting | October 13-16, 2024
Together with Martin Heitmann, he will give a presentation on the topic “GAMP 5 Second Edition as a starting point: AI governance in the regulated areas is taking shape”. They will focus in particular on Appendix D11_ Fundamentals of the life cycle of machine learning systems. They will also talk about AI and the eClinical Practice Guide, which provides a detailed view of artificial intelligence in GCP. This is followed by a VDI expert recommendation from the GAMP D-A-CH SIG with a comprehensive view of ML governance. Finally, they will give an outlook on further initiatives and on contributions to regulators’ initiatives.
You can find further information on the presentation and the ISPE annual meeting 2024 here.