{"id":13958,"date":"2025-05-30T14:35:06","date_gmt":"2025-05-30T12:35:06","guid":{"rendered":"https:\/\/q-finity.de\/?p=13958"},"modified":"2026-07-15T14:25:40","modified_gmt":"2026-07-15T12:25:40","slug":"ispe-webinar-with-qfinity-05-june-2025","status":"publish","type":"post","link":"https:\/\/q-finity.de\/en\/ispe-webinar-with-qfinity-05-june-2025\/","title":{"rendered":"ISPE Webinar with QFINITY | June 5, 2025"},"content":{"rendered":"<p data-start=\"0\" data-end=\"486\"><a href=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/05\/Bildschirmfoto-2025-05-30-um-14.11.15.png\"><img data-opt-id=1013031255  fetchpriority=\"high\" decoding=\"async\" class=\"alignright wp-image-13947\" title=\"ISPE-Webinar 2025\" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:300\/h:66\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/05\/Bildschirmfoto-2025-05-30-um-14.11.15.png\" alt=\"ISPE-Webinar 2025\" width=\"413\" height=\"91\" srcset=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:300\/h:66\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/05\/Bildschirmfoto-2025-05-30-um-14.11.15.png 300w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:1030\/h:227\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/05\/Bildschirmfoto-2025-05-30-um-14.11.15.png 1030w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:768\/h:169\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/05\/Bildschirmfoto-2025-05-30-um-14.11.15.png 768w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:1536\/h:338\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/05\/Bildschirmfoto-2025-05-30-um-14.11.15.png 1536w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:1920\/h:422\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/05\/Bildschirmfoto-2025-05-30-um-14.11.15.png 2048w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:1500\/h:330\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/05\/Bildschirmfoto-2025-05-30-um-14.11.15.png 1500w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:705\/h:155\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/05\/Bildschirmfoto-2025-05-30-um-14.11.15.png 705w\" sizes=\"(max-width: 413px) 100vw, 413px\"><\/a>On June 5, 2025, our Senior Executive Consultant, Frank Henrichmann, will be speaking at the ISPE webinar <em data-start=\"106\" data-end=\"195\">&ldquo;<a href=\"https:\/\/q-finity.de\/en\/glossar\/audit\/\" target=\"_self\" title=\"An Audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled.\" class=\"encyclopedia\">Audit<\/a> and Oversight Challenges in GCP Systems, with a Focus on Clinical Site Systems.&rdquo;<\/em> This free webinar is aimed at professionals with an intermediate level of experience and will explore the challenges involved in auditing and oversight of computerized systems in accordance with Good Clinical Practice (GCP) guidelines. It will focus in particular on clinical site systems.<\/p>\n<p data-start=\"488\" data-end=\"507\"><strong data-start=\"488\" data-end=\"507\">Webinar Topics:<\/strong><\/p>\n<ul data-start=\"509\" data-end=\"1161\">\n<li data-start=\"509\" data-end=\"710\">\n<p data-start=\"511\" data-end=\"710\"><strong data-start=\"511\" data-end=\"543\">Importance of Clinical <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation.\" class=\"encyclopedia\">Data<\/a>:<\/strong> Understanding the critical role of data from clinical sites in the success of clinical trials and the risks associated with inadequate system validation or oversight.<\/p>\n<\/li>\n<li data-start=\"712\" data-end=\"907\">\n<p data-start=\"714\" data-end=\"907\"><strong data-start=\"714\" data-end=\"742\">Regulatory Expectations:<\/strong> An overview of EMA guidelines on computerized systems and electronic data in clinical trials, with an emphasis on compliance, data integrity, and system validation.<\/p>\n<\/li>\n<li data-start=\"909\" data-end=\"1161\">\n<p data-start=\"911\" data-end=\"1161\"><strong data-start=\"911\" data-end=\"939\">Challenges for Sponsors:<\/strong> A discussion of the difficulties sponsors face in establishing robust oversight of systems used at clinical sites, particularly in decentralized and hybrid trial models, to ensure regulatory compliance and data integrity.<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"1163\" data-end=\"1461\">This webinar is based on the <em data-start=\"1192\" data-end=\"1326\">&ldquo;GAMP&reg; Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data &ndash; Good eClinical Practice (2nd Edition).&rdquo;<\/em> It offers practical insights and best practices for system validation and effective collaboration between sponsors and clinical sites.<\/p>\n<p data-start=\"1463\" data-end=\"1485\"><strong data-start=\"1463\" data-end=\"1485\">About the Speaker:<\/strong><\/p>\n<p data-start=\"1487\" data-end=\"1637\">Frank Henrichmann brings extensive expertise in quality management and computerized systems and will share valuable insights from his work at QFINITY.<\/p>\n<p data-start=\"1639\" data-end=\"1656\"><strong data-start=\"1639\" data-end=\"1656\">Registration:<\/strong><\/p>\n<p data-start=\"1658\" data-end=\"1821\" data-is-last-node=\"\" data-is-only-node=\"\">You can register for the ISPE webinar 2025 <a class=\"\" href=\"https:\/\/ispe.org\/webinars\/audit-and-oversight-challenges-gcp-systems-focus-clinical-site-systems\" target=\"_new\" rel=\"noopener\" data-start=\"1716\" data-end=\"1820\">here<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On June 5, 2025, our Senior Executive Consultant, Frank Henrichmann, will be speaking at the ISPE webinar &#8220;Audit and Oversight Challenges in GCP Systems, with a Focus on Clinical Site Systems.&#8221; This free webinar is aimed at professionals with an intermediate level of experience and will explore the challenges involved in auditing and oversight of [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":13947,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[38],"tags":[],"class_list":["post-13958","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 Webinar: GCP Systems Audit | QFINITY<\/title>\n<meta name=\"description\" content=\"Frank Henrichmann spoke at the free ISPE webinar on audit and oversight of GCP systems in clinical trials, held online on June 5, 2025.\" \/>\n<meta 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