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Where you meet us in person.

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.

Latest events

Conferences, talks and webinars.

Live-Online-Training GxP Systems Digital Compliance - QFINITY

The live online training “GxP Systems & Digital Compliance Fundamentals” takes place on 8 May 2026. QFINITY CEO Oliver Herrmann will deliver the training together with Martin Heitmann. The focus is on AI compliance, GMP requirements, Annex 11, and the Annex 22 Draft. The session will also present practical approaches for using AI safely in regulated GxP environments.

Artificial intelligence is making its way into more and more GMP-relevant processes and systems. This creates new opportunities – and new requirements for validation, data integrity, governance, and inspection readiness. The training addresses exactly this interface. It covers fundamentals and current developments in computerized systems and digital compliance, along with the regulatory-compliant use of AI in the GMP environment.

Participants will get a structured overview of the current Annex 11 requirements. The session will also discuss the possible impact of the revised Annex 11 drafts and the new regulatory perspectives arising from the Annex 22 Draft, and will include the ISPE GAMP perspective on good practices for the quality of computerized systems. A particular focus is the effective, safe, and compliance-oriented use of AI in GxP environments.

Oliver Herrmann, CEO and Founder of QFINITY, and Martin Heitmann will deliver the training. Oliver Herrmann is an internationally recognized expert in validation, technology quality, data integrity, and system implementation. Martin Heitmann brings extensive expertise in GAMP AI and GxP compliance. Among other roles, he is Co-Lead of the ISPE GAMP Guide: Artificial Intelligence.

You can find further information about the training here. For more QFINITY events, see Meet QFINITY.

Veranstaltungsbanner: ISPE EU Jahreskonferenz | 20-22. April 2026

Meet QFINITY on site at the ISPE EU Annual Conference 2026 in Copenhagen and learn how to bring digital compliance, AI, and GxP requirements together in a safe, future-proof, and practical way.

  • Event: ISPE EU Annual Conference 2026
  • Location: Copenhagen, Denmark, and virtual
  • Date: April 20-22, 2026
  • Organizer: International Society for Pharmaceutical Engineering
  • QFINITY Role: Program Team & Track Lead Digital Compliance

QFINITY’s Contribution to ISPE Europe 2026

The digital transformation of the pharmaceutical industry is progressing rapidly. Artificial intelligence, cloud technologies, and data-driven automation are now integral to GxP-critical processes. At the same time, regulatory requirements for data integrity, transparency, and patient safety remain uncompromising.

Oliver Herrmann, CEO of QFINITY, is a member of the event’s Program Team. He also serves as Track Lead for the Digital Compliance track, together with Josef Trapl and Niels de Blende. In this role, he is responsible for the track’s structure, technical depth, and overall content direction.

Content Focus: Digital Compliance

The Digital Compliance track addresses one central question:

How do you ensure lasting GxP compliance in AI-enabled, cloud-based, and continuously evolving system landscapes?

1. GxP Principles in the Age of AI

  • Risk-based application of GAMP principles to AI systems
  • Compliance-by-design for automation and cloud architectures
  • Clear accountability for automated decisions

2. From Document-Based to Data-Driven Validation

  • Digital, record-based validation approaches
  • Inspection-ready, data-centric evidence
  • Scalable Validation 4.0 models

3. Data Integrity, Trust, and Decision-Making

  • Practical data integrity concepts
  • Audit trail design and review in complex GxP landscapes
  • Traceable models for AI-supported review by exception

4. Next Generation Digital Compliance

  • End-to-end validation of AI systems
  • Intelligent agents and embedded compliance
  • Explainability as the foundation of regulatory trust

For more information about the event and to register for the ISPE EU Annual Conference, please visit the ISPE website.

Veranstaltungsbanner: ACDM26 Konferenz mit QFINITY | 15-17 März 2026

QFINITY will participate in the ACDM26 Conference in Berlin. The international conference is one of the leading events for professionals in Clinical Data Management and clinical research. It also draws experts in regulatory affairs and digital innovation across the life sciences industry.

As part of the conference program, Frank Henrichmann, Senior Executive Consultant at QFINITY, will deliver a presentation titled “Rewriting the Rulebook: How AI Will Transform Computer System Validation.”

The presentation will explore how Artificial Intelligence (AI) could fundamentally transform Computerized System Validation (CSV) in GxP-regulated environments. Traditional validation approaches are often time-consuming, highly manual, and resource-intensive.

The session will demonstrate how modern AI technologies may one day analyze and structure requirements, generate and execute test cases, and automatically document validation evidence. This has the potential to make the validation of clinical systems more efficient. It could also enable continuous compliance monitoring and improve audit readiness.

At the same time, the presentation highlights that the success of this transformation depends heavily on high-quality, well-structured requirements. It will also address key challenges such as the regulatory acceptance of AI-generated evidence, the validation of the AI tools themselves, and the role of human oversight in AI-supported validation processes.

Key Learning Objectives of the Presentation

Participants will gain insights into three central aspects of AI-supported validation:

1. Application of AI in system validation
Understanding how AI technologies can be applied to the validation of GCP and other clinical systems. In particular, it shows how they can improve efficiency, test coverage, and compliance.

2. Importance of high-quality requirements
Recognizing the critical role that precise, structured, and complete requirements play in enabling successful AI-supported validation.

3. Transition to AI-supported validation processes
Identifying key challenges and practical steps involved in moving from traditional CSV approaches to AI-supported validation workflows in regulated environments.

Exchange at ACDM26

The ACDM26 conference provides a platform for international exchange on current developments in Clinical Data Management. It also covers emerging technological and regulatory challenges in clinical research.

QFINITY looks forward to contributing to the discussion. The focus will be on how AI, regulatory requirements, and technological innovation will shape the future of Computer System Validation.

You can find further information about the ACDM26 Conference here.