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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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Events, case studies and insights.

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QFINITY’s Senior Executive Consultant at the ISPE Annual Meeting | October 13-16, 2024

QFINITY’s Senior Executive Consultant Frank Henrichmann will be attending the ISPE Annual Meeting 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.

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ISPE Annual Meeting with QFINITY’s CEO | October 13-16, 2024

The CEO of QFINITY, Oliver Herrmann, will be attending the ISPE Annual Meeting again this year.

The event will take place from October 13-16 in Orlando, Florida. You can attend both virtually and in person. You can find further registration information here.

Oliver Herrmann will give a presentation on-site. Together with the discussion that follows, his presentation will answer the following question.

Are the current EU GCP CSV/DI requirements a blueprint for other GxPs?

Interested in the presentation and the discussion? Then register now for the ISPE Annual Meeting. We look forward to meeting you on-site.

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QFINITY’s Senior Executive Consultant with presentation at GQMA Annual Meeting | September 19-20, 2024

The German Management Quality Association was founded in 1995 and now has over 900 members. Its members work in various branches of industry, contract institutes, clinical laboratories and departments as well as industrial laboratories, clinics and public authorities. The GQMA’s main objectives are to promote the exchange of scientific information and opinions and to support education and training for specific purposes.

QFINITY’s Senior Executive Consultant Dr. Jenny Gebhardt will present the brand new second edition of the ISPE GAMP Good eClinical Practice Guide at the 28th Annual Meeting of the German Management Quality Association.

The annual meeting will take place on September 19-20, 2024 in Neuss, Germany.

You can find further information about the GQMA here.

You can find further information on the ISPE GAMP Good Practice Guide for eClinical Systems here.