6th GAMP Conference: GxP in the Cloud

QFINITY chairs the 6th GAMP Conference “GxP in the Cloud” in Mannheim (December 10, 2026): regulator, pharma QA and cloud providers at one table – with the guiding question of how control stays demonstrable when cloud, SaaS and AI change continuously.

Oliver Herrmann (QFINITY) and Frank Henrichmann jointly lead the conference. Date: December 10, 2026 in Mannheim – part of the GAMP conference week by ISPE, APV, Concept Heidelberg and VDI/VDE-GMA. The leitmotif: Cloud. AI. Continuous Assurance.

Who has to provide the evidence when the cloud changes overnight?

Cloud, SaaS, PaaS and AI change continuously – the provider delivers the platform and technical controls, while responsibility for intended use, validation, oversight and verifiable evidence stays with the regulated company.

Who is at the table

What matters most are the three perspectives that decide whether GxP cloud use holds up – and all of them are represented:

Regulator / authority: Dr. Arno Terhechte (Bezirksregierung Münster)
Pharma & QA: Hans Jochem Harnisch (Bayer AG), Susanna Nagel (Roche)
Cloud & supplier: Bill Reid (Google Cloud), Robert Geiger-Lebailly (SAP SE), David Garonzik (Validated Cloud), Sebastian Koch (p36)
Industry & consulting: Marcel Geers (Porsche Consulting), Gennadij Zarnikov and Cecilia Lo (Tenthpin Solutions)

Key topics

Shared responsibility – where does the provider’s platform responsibility end and your own GxP evidence duty begin?
Annex 11 draft – supplier oversight, SLAs, control logic and evidence for modern cloud services.
AI use cases and governance – use-case classification, GxP relevance, human oversight and decision paths.
Validation and a controlled operating phase – from a validated go-live to continuously demonstrable control.
Scalable supplier oversight – covering hyperscalers via group audits instead of a repeated audit marathon.
Cloud qualification evidence – classifying, adopting and bringing provider evidence into your own QMS.