{"id":15640,"date":"2026-07-01T06:49:33","date_gmt":"2026-07-01T04:49:33","guid":{"rendered":"https:\/\/q-finity.de\/30th-gqma-annual-conference-with-qfinity-september-17-18-2026\/"},"modified":"2026-07-15T14:25:25","modified_gmt":"2026-07-15T12:25:25","slug":"30th-gqma-annual-conference-with-qfinity-september-17-18-2026","status":"publish","type":"post","link":"https:\/\/q-finity.de\/en\/30th-gqma-annual-conference-with-qfinity-september-17-18-2026\/","title":{"rendered":"30th GQMA Annual Conference with QFINITY | September 17-18, 2026"},"content":{"rendered":"<p class=\"qf-abstract\">At the 30th GQMA Annual Conference, Frank Henrichmann (QFINITY) leads the workshop &ldquo;AI in <a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system-validation\/\" target=\"_self\" title=\"Computerized system validation describes achieving and maintaining compliance with applicable GxP and Medical Device regulations and establishing documented evidence that the system is fit for intended use by: the adoption of principles, approaches, and life cycle activities within the validation framework by executing project specific validation plans establishing and applying&nbsp;appropriate operational controls throughout the life&hellip;\" class=\"encyclopedia\">Computerized System Validation<\/a>&rdquo; &ndash; how AI, in particular large language models and generative AI-enabled tools, can be integrated across the entire CSV lifecycle, in line with <a href=\"https:\/\/q-finity.de\/en\/glossar\/gamp-5-begriff\/\" target=\"_self\" title=\"GAMP 5 - &quot;A Risk-Based Approach to Compliant GxP Computerized Systems&quot; - is ISPE's industry guide to the validation of computerized systems: published in 2008, and available since 2022 in the Second Edition, which strengthens critical thinking and scaled evidence. GAMP is industry good practice, not law: regulations set the requirements - GAMP shows a&hellip;\" class=\"encyclopedia\">GAMP 5<\/a> Second Edition and CSA. Friday, September 18, 2026, 11:05-11:50.<\/p>\n<p>The 30th Annual Conference of the GQMA (German <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality-management\/\" target=\"_self\" title=\"Quality Management (QM) refers to all organizational measures that relate to the structure of the organization and the efficient execution of processes at various levels of the company. With consistent implementation, quality management enables the continuous improvement of corporate culture, process quality and technology deployment, ultimately leading to better products or services.\" class=\"encyclopedia\">Quality Management<\/a> Association) takes place on September 17-18, 2026 at the Dorint Hotel Potsdam and focuses on quality management in the chemical and pharmaceutical industries across all GxP areas &ndash; with parallel streams on IT, GMP, GxP, AI, GLP, GCP, and pharmacovigilance.<\/p>\n<h2>The workshop<\/h2>\n<p>In the AI\/CSV workshop stream, Frank Henrichmann shows in practice how AI-enabled tools can already support the validation of computerized systems today &ndash; building on the ISPE article &ldquo;How AI Will Transform <a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system\/\" target=\"_self\" title=\"The term computerized system covers a broad range of systems including, but not limited to, automated laboratory equipment, laboratory information management, clinical trials data management, vigilance systems, process control and process analytics, manufacturing resource planning, automated manufacturing equipment, manufacturing execution, and document management systems. The computerized system consists of the hardware, software, and network components,&hellip;\" class=\"encyclopedia\">Computerized System<\/a> Validation.&rdquo; Using a sample system and a generally available language model, participants work through, among others:<\/p>\n<ul>\n<li>Structured capture, assessment, and mapping of requirements<\/li>\n<li>Risk-based validation planning<\/li>\n<li>Automated generation of test cases<\/li>\n<li>Creation of traceability matrices<\/li>\n<\/ul>\n<p>The discussion covers the limits and risks of using AI in validation, regulatory acceptance, the critical role of the &ldquo;human in the loop,&rdquo; and the shift in the validation team&rsquo;s role &ndash; away from document handling toward &ldquo;quality architects.&rdquo;<\/p>\n<blockquote class=\"qf-pullquote\">\n<p>The validation team&rsquo;s role is shifting &ndash; away from pure document handling toward quality architects.<\/p>\n<\/blockquote>\n<p>Speaker: Frank Henrichmann, Senior Executive Consultant at QFINITY and Chair of the global GAMP Steering Committee. Focus: IT; level: intermediate; presentation language: German. Registration from late April.<\/p>\n<p><a class=\"qf-extref\" href=\"https:\/\/www.gqma.de\" target=\"_blank\" rel=\"noopener\"><span class=\"qf-extref-text\">Program and registration at GQMA (gqma.de)<\/span><span class=\"qf-extref-arrow\">&#8599;<\/span><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>At the 30th GQMA Annual Conference, Frank Henrichmann (QFINITY) leads the workshop &#8220;AI in Computerized System Validation&#8221; &#8211; how AI, in particular large language models and generative AI-enabled tools, can be integrated across the entire CSV lifecycle, in line with GAMP 5 Second Edition and CSA. Friday, September 18, 2026, 11:05-11:50. The 30th Annual Conference [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":15639,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[38],"tags":[],"class_list":["post-15640","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-meet-qfinity-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>GQMA Annual Conference: AI in CSV | QFINITY<\/title>\n<meta name=\"description\" content=\"Frank Henrichmann (QFINITY) leads the &quot;AI in CSV&quot; workshop at the 30th GQMA Annual Conference on September 18, 2026 - GAMP 5, CSA and LLMs.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/q-finity.de\/en\/30th-gqma-annual-conference-with-qfinity-september-17-18-2026\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GQMA Annual Conference: AI in CSV | QFINITY\" \/>\n<meta property=\"og:description\" content=\"Frank Henrichmann (QFINITY) leads the &quot;AI in CSV&quot; 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