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An overview of the events QFINITY takes part in or has attended, from conferences and talks to webinars. These include our own workshops as well as reports from events of ISPE, ACDM and other associations. Stop by and talk to us in person.

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Conferences, talks and webinars.

3rd GAMP Conference: Artificial Intelligence Meets the Pharmaceutical Industry with QFINITY | December 10, 2026

3rd GAMP Conference: Artificial Intelligence Meets the Pharmaceutical Industry - QFINITY

At the 3rd GAMP Conference “Artificial Intelligence Meets Pharma” in Mannheim (December 10, 2026), Oliver Herrmann speaks on progressive QA in complex regulated environments – the architecture of computerized systems, the role of humans and the responsible use of AI.

The conference takes place on December 10, 2026 in Mannheim – a joint event of ISPE, APV, Concept Heidelberg and VDI/VDE-GMA. The focus: using AI in the regulated GxP environment – regulatory expectations (EU GMP Annex 22), practical implementation, the role of QA, supplier relationships and security aspects. It directly follows the GAMP 5 Conference (December 8-9) and the pre-conference introductory training (December 7).

The talk

“Progressive QA in complex regulated environments: the architecture of computerized systems, the role of humans and the responsible use of AI” – the key themes:

  • On silos and progressive QA: the context of regulated environments
  • Quality as the result of linked processes, data, software and interfaces
  • Responsible AI in process and system architecture
  • The central role of humans: judgment, oversight and accountability
  • The QA shift: from single-system testing to actively shaping digital system landscapes

Quality emerges from the interplay of processes, data, software and interfaces – not from testing a single system.

6th GAMP Conference GxP in the Cloud with QFINITY | December 10, 2026

6th GAMP Conference: GxP in the Cloud - QFINITY

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.

Official GAMP 5 Pre-Conference Beginner Training with QFINITY | December 7, 2026

19th Official GAMP 5 Conference - December 8–9, 2026, Mannheim

On December 7, 2026 in Mannheim, Oliver Herrmann (QFINITY) – together with Jens Lambertz and Martin Heitmann – leads the official GAMP 5 pre-conference introductory training, the compact warm-up to the 19th GAMP 5 Conference, covering the fundamentals of risk-based CSV per GAMP 5 Second Edition and an outlook on AI.

The official GAMP 5 pre-conference introductory training takes place on Monday, December 7, 2026 in Mannheim – the kick-off to the 19th Official GAMP 5 Conference (December 8-9). A joint event of ISPE, APV, Concept Heidelberg and VDI/VDE-GMA.

QFINITY as trainer

Oliver Herrmann leads the training together with Jens Lambertz and Martin Heitmann and covers the fundamentals of risk-based validation of computerized systems per GAMP 5 Second Edition – with a focus on CSV basics and placing artificial intelligence in the regulated environment.

  • Risk-based CSV per GAMP 5 Second Edition
  • From the fundamentals to practical application
  • Placing AI in the regulated GxP environment

Built from the foundation up – risk-based validation made clear for newcomers.

Program and registration at the organizer (gamp-dach.de)↗