{"id":15642,"date":"2026-07-01T06:49:47","date_gmt":"2026-07-01T04:49:47","guid":{"rendered":"https:\/\/q-finity.de\/ispe-annual-meeting-and-expo-with-qfinity-october-18-21-2026\/"},"modified":"2026-10-26T09:56:44","modified_gmt":"2026-10-26T08:56:44","slug":"2026-ispe-annual-meeting-expo-with-qfinity-october-18-21-2026","status":"publish","type":"post","link":"https:\/\/q-finity.de\/en\/2026-ispe-annual-meeting-expo-with-qfinity-october-18-21-2026\/","title":{"rendered":"ISPE Annual Meeting & Expo with QFINITY | October 18-21, 2026"},"content":{"rendered":"

We are glad to be at the 2026 ISPE Annual Meeting & Expo!<\/p>\n

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.<\/p>\n

QFINITY on stage<\/h2>\n

Two sessions in the “Digital – Data<\/a> – Decision Integrity” track show how quality assurance and computerized system validation evolve as AI enters regulated GxP environments<\/a> – moving away from mere documentation management toward deliberately designed system architecture.<\/p>\n

Progressive QA in AI-Enabled GxP Environments<\/h3>\n

Oliver Herrmann<\/strong> (QFINITY) and Martin Heitmann<\/strong> (MH Consulting & Advisory GmbH)<\/p>\n

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<\/a> 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.<\/p>\n

AI-Enabled Computerized System Validation<\/h3>\n

Frank Henrichmann<\/strong> (QFINITY)<\/p>\n

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)<\/a>, aligned with GAMP 5<\/a> Second Edition and CSA principles? Building on the ISPE Magazine article “How AI Will Transform Computerized System Validation<\/a>,” 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.<\/p>\n

Session and registration in the ISPE program (ispe.org)<\/span>↗<\/span><\/a><\/p>\n

Attending in person? Reach out – we look forward to connecting.<\/p>\n