{"id":13958,"date":"2025-05-30T14:35:06","date_gmt":"2025-05-30T12:35:06","guid":{"rendered":"https:\/\/q-finity.de\/?p=13958"},"modified":"2025-06-16T10:52:58","modified_gmt":"2025-06-16T08:52:58","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 | 05. June 2025"},"content":{"rendered":"<p data-start=\"0\" data-end=\"486\"><a href=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/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:frAi.c2d9\/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:frAi.c2d9\/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:frAi.c2d9\/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:frAi.c2d9\/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:frAi.c2d9\/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:frAi.c2d9\/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:frAi.c2d9\/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:frAi.c2d9\/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. If you need more information about audits please contact us here.\" 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. Special focus will be placed 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. If you need more information about data contact us here.\" class=\"encyclopedia\">Data<\/a>:<\/strong> Understanding the critical role of <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. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> 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 <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. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> in clinical trials, with an emphasis on compliance, <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. If you need more information about data integrity contact us here.\" class=\"encyclopedia\">data integrity<\/a>, 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 <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. If you need more information about data integrity contact us here.\" class=\"encyclopedia\">data integrity<\/a>.<\/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 <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. If you need more information about data contact us here.\" class=\"encyclopedia\">Data<\/a> &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 <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. If you need&hellip;\" class=\"encyclopedia\">quality management<\/a> and computerized systems and will share valuable insights from his work at <a href=\"https:\/\/q-finity.de\/en\/glossar\/qfinity\/\" target=\"_self\" title=\"QFINITY provides expertise and support for pharmaceutical and medical device companies along the entire product or service lifecycle. Our focus is on developing and optimizing quality management system and IT system strategies to support continuous improvement, (business) process management and optimization through application of technology, ensuring (e)data quality and data integrity, as well as validation&hellip;\" class=\"encyclopedia\">QFINITY<\/a>.<\/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=\"\">Interested participants 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":0,"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","hentry","category-meet-qfinity-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>ISPE Webinar 2025 with QFINITY<\/title>\n<meta name=\"description\" content=\"Frank Henrichmann, will be at the ISPE webinar &quot;Audit and Oversight Challenges in GCP Systems, with a Focus on Clinical Site Systems.&quot;\" \/>\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\/ispe-webinar-with-qfinity-05-june-2025\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISPE Webinar with QFINITY | 05. June 2025\" \/>\n<meta property=\"og:description\" content=\"Frank Henrichmann, will be at the ISPE webinar &quot;Audit and Oversight Challenges in GCP Systems, with a Focus on Clinical Site Systems.&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/ispe-webinar-with-qfinity-05-june-2025\/\" \/>\n<meta property=\"og:site_name\" content=\"QFINITY\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/QFINITY\" \/>\n<meta property=\"article:published_time\" content=\"2025-05-30T12:35:06+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-06-16T08:52:58+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/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\" \/>\n\t<meta property=\"og:image:width\" content=\"2324\" \/>\n\t<meta property=\"og:image:height\" content=\"512\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Maike Henrichmann\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@cQFINITY\" \/>\n<meta name=\"twitter:site\" content=\"@cQFINITY\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Maike Henrichmann\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/q-finity.de\/en\/ispe-webinar-with-qfinity-05-june-2025\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/q-finity.de\/en\/ispe-webinar-with-qfinity-05-june-2025\/\"},\"author\":{\"name\":\"Maike Henrichmann\",\"@id\":\"https:\/\/q-finity.de\/en\/#\/schema\/person\/9f304da5294d2d15c3f03d2521c47921\"},\"headline\":\"ISPE Webinar with QFINITY | 05. 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