QFINITY · Events · Meet QFINITY
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
Official GAMP 5 Basic Principles Training with QFINITY | October 22-23, 2026
Frank Henrichmann (QFINITY) will lead the official two-day GAMP 5 Basic Principles training in person at the ISPE Annual Meeting 2026 in National Harbor (Washington, D.C.) – a practical introduction to risk-based compliance for computerized systems based on the GAMP 5 Guide (Second Edition). October 22-23, 2026, Gaylord National Resort, National Harbor (Washington, D.C.), USA.
The official ISPE training course “Basic Principles of Computerized Systems Compliance” teaches the internationally recognized methods for ensuring that computerized systems in the pharmaceutical, biotech, and medical device industries comply with regulatory requirements and are “fit for intended use” – directly from the GAMP 5 Guide, Second Edition.
Contents
Format: 2-day in-person course (8:30 a.m.-4:30 p.m. EDT), Fundamental level, language: English, 1.3 ISPE CEUs. Trainer: Frank Henrichmann, Senior Executive Consultant at QFINITY and Chair of the Global GAMP Steering Committee. The training immediately follows the ISPE Annual Meeting & Expo (October 18-21).
Course details and registration via ISPE (ispe.org)↗
ISPE AI in Life Sciences Summit with QFINITY | June 22-23, 2026
QFINITY will be at the ISPE AI in Life Sciences Summit 2026 in Boston. The event takes place June 22-23 and brings together international experts in life sciences, validation, compliance, and digital innovation. The program focuses on current developments in the use of artificial intelligence in GxP-regulated environments.
Frank Henrichmann, Senior Executive Consultant at QFINITY, plays a special role: he is a member of the summit’s Program Committee and serves as the Track Lead for the “Validation & GAMP Track.” In this role, he is responsible for a topic area that takes a practical approach to validating AI-enabled computerized systems.
The Validation & GAMP Track is based on the principles of the ISPE GAMP Framework and the GAMP AI Guide. It also addresses key issues currently facing companies: from risk assessment, lifecycle management, and model monitoring to inspection readiness and the compliant integration of AI into regulated processes.
We are pleased to be part of this event and to play an active role in advancing practical, regulatory-compliant approaches to using AI in the life sciences industry.
You can find more information about the event here.
ISPE Annual Meeting & Expo with QFINITY | October 18-21, 2026
We are glad to be at the 2026 ISPE Annual Meeting & Expo!
It takes place October 18-21, 2026 at the Gaylord National Resort & Convention Center in National Harbor (Washington, D.C. metro area) – one of the central international conferences for the pharma and life-sciences industry. A virtual attendance option is also available.
QFINITY on stage
Two sessions in the “Digital – Data – Decision Integrity” track show how quality assurance and computerized system validation evolve as AI enters regulated GxP environments – moving away from mere documentation management toward deliberately designed system architecture.
Progressive QA in AI-Enabled GxP Environments
Oliver Herrmann (QFINITY) and Martin Heitmann (MH Consulting & Advisory GmbH)
AI is not simply introducing new tools – it changes how GxP computerized systems operate: execution shifts toward supervision, and deterministic behavior turns probabilistic. This does not reduce the need for quality assurance – it elevates it. Quality no longer emerges from validating isolated systems, but from the interaction of business processes, data, software, interfaces, and decision structures. QA evolves from a pure control function into an architect of controlled, reliable digital system landscapes. Responsible AI is not an add-on: it must be embedded into system architecture – including intended use, human oversight, and risk-based controls across the full lifecycle.
AI-Enabled Computerized System Validation
Frank Henrichmann (QFINITY)
How can AI technologies – particularly large language models, machine-learning-driven analytics, and generative AI – be integrated into the end-to-end lifecycle of computerized system validation (CSV), aligned with GAMP 5 Second Edition and CSA principles? Building on the ISPE Magazine article “How AI Will Transform Computerized System Validation,” the talk moves beyond vision and theory to what is already possible today: requirement gathering and mapping, automated test-case generation, test execution and evidence capture, auto-generation of traceability matrices, and risk-based validation planning. Validation-team roles shift along the way – from documentation management to “quality architect” responsibilities that design validation approaches and review AI-generated output to ensure compliance and quality.
Session and registration in the ISPE program (ispe.org)↗
Attending in person? Reach out – we look forward to connecting.