{"id":8456,"date":"2023-03-30T15:26:09","date_gmt":"2023-03-30T13:26:09","guid":{"rendered":"https:\/\/q-finity.de\/?p=8456"},"modified":"2026-07-07T14:49:29","modified_gmt":"2026-07-07T12:49:29","slug":"may-06-10-2023-ispe-europe-annual-conference","status":"publish","type":"post","link":"https:\/\/q-finity.de\/en\/may-06-10-2023-ispe-europe-annual-conference\/","title":{"rendered":"May 06-10, 2023 | ISPE Europe Annual Conference"},"content":{"rendered":"<p>Oliver Herrmann and Frank Henrichmann from QFINITY will be at this year&rsquo;s ISPE Europe Annual Conference.<\/p>\n<p>Frank Henrichmann organizes and moderates the <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> track at the ISPE EU Annual Meeting.<\/p>\n<p>Oliver Herrmann will lead a workshop there with Elena Vulpe on GAMP 5 Second Edition &ndash; <a href=\"https:\/\/q-finity.de\/en\/glossar\/data-integrity\/\" target=\"_self\" title=\"Data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should meet the ALCOA++ criteria. Ensuring data integrity requires appropriate quality and risk management systems and compliance with good documentation practices.\" class=\"encyclopedia\">Data Integrity<\/a>\/<a href=\"https:\/\/q-finity.de\/en\/glossar\/computer-software-assurance-csa\/\" target=\"_self\" title=\"Computer Software Assurance is the FDA's risk-based approach for establishing and maintaining confidence that software is fit for its Intended Use - in the guidance's own wording, the Intended Use of the software as part of production or the quality management system, explicitly distinguished from the intended use of the medical device itself. The effort&hellip;\" class=\"encyclopedia\">Computer Software Assurance (CSA)<\/a>. In this interactive workshop, participants will discuss and analyze practical examples together with the developers of the CSA guidelines and practitioners from the EU and the US. Oliver and Elena will be supported by Ken Shitamoto, Ray Murphy and Khaled Moussally from the FISCA team.<\/p>\n<p>&nbsp;<\/p>\n<p>You can find more information and details about the program on the ISPE website.<\/p>\n<p><a href=\"https:\/\/ispe.org\/conferences\/2023-europe-annual-conference\/programme\">https:\/\/ispe.org\/conferences\/2023-europe-annual-conference\/programme<\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Oliver Herrmann and Frank Henrichmann from QFINITY will be at this year&#8217;s ISPE Europe Annual Conference. Frank Henrichmann organizes and moderates the GAMP 5 track at the ISPE EU Annual Meeting. Oliver Herrmann will lead a workshop there with Elena Vulpe on GAMP 5 Second Edition &#8211; Data Integrity\/Computer Software Assurance (CSA). In this interactive [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":10413,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[38],"tags":[],"class_list":["post-8456","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>ISPE Europe Annual Conference: GAMP 5 &amp; CSA | QFINITY<\/title>\n<meta name=\"description\" content=\"At the ISPE Europe Annual Conference (May 6-10, 2023), Frank Henrichmann organized the GAMP 5 track and Oliver Herrmann led a GAMP 5 2nd Edition workshop.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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