{"id":8097,"date":"2023-03-17T10:04:36","date_gmt":"2023-03-17T09:04:36","guid":{"rendered":"https:\/\/q-finity.de\/?p=8097"},"modified":"2023-03-17T10:10:52","modified_gmt":"2023-03-17T09:10:52","slug":"april-18-2023-lounges-in-karlsruhe","status":"publish","type":"post","link":"https:\/\/q-finity.de\/en\/april-18-2023-lounges-in-karlsruhe\/","title":{"rendered":"April 18, 2023 | Lounges in Karlsruhe"},"content":{"rendered":"<p>Oliver Herrmann (CEO and founder of <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>) and Frank Henrichmann (Senior Executive Consultant 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>) will give two presentations at the Lounges in Karlsruhe.<\/p>\n<p>Oliver Herrmann will give a presentation on the topic <span class=\"TextRun SCXW242898520 BCX4\" lang=\"DE-DE\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW242898520 BCX4\">GAMP&reg;5 &ndash; 2nd Edition<\/span> <span class=\"NormalTextRun SCXW242898520 BCX4\">&ndash; Applying the Key<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SpellingErrorHighlight SCXW242898520 BCX4\">Principles<\/span> <span class=\"NormalTextRun SCXW242898520 BCX4\">to enable Innovation<\/span><\/span><\/p>\n<p><span data-contrast=\"none\">The presentation will<\/span> <span data-contrast=\"none\">provide an introduction to the key principles <\/span><span data-contrast=\"none\"> of GAMP 5 Second Edition and how they apply in an ever-changing world In addition, the new GAMP Guides will be briefly introduced. Key challenges arise in the areas of <a href=\"https:\/\/q-finity.de\/en\/glossar\/critical-thinking\/\" target=\"_self\" title=\"Critical thinking is a systematic, rational, and disciplined process of evaluating information from a variety of perspectives to yield a balanced and well-reasoned answer. Critical thinking promotes informed decision-making and good judgment about where and how to apply and scale quality and compliance activities for computerized systems based on the risks associated with them. A&hellip;\" class=\"encyclopedia\">Critical Thinking<\/a>\/CSA\/RBA, AI, Agile and IS (Cloud) Management. In addition, the presentation will give an overview and first practical experiences in the application of these special topics as well as their integrated implementation in projects.<\/span><\/p>\n<p>Frank Henrichmann will give a presentation about the topic <span class=\"TextRun SCXW228412906 BCX4\" lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW228412906 BCX4\">GAMP 5 Second Edition<\/span> &ndash; <span class=\"NormalTextRun SpellingErrorV2Themed SCXW228412906 BCX4\">Specifying<\/span><\/span> <span class=\"EOP SCXW228412906 BCX4\" data-ccp-props=\"{}\">Requirements<\/span><\/p>\n<p><span class=\"TextRun SCXW227108283 BCX4\" lang=\"DE-DE\" xml:lang=\"DE-DE\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW227108283 BCX4\">The presentation will provide an introduction to GAMP 5 Second Edition in general and then explore<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SpellingErrorHighlight SCXW227108283 BCX4\">Requirements<\/span><span class=\"NormalTextRun SCXW227108283 BCX4\"> Management. After all, GAMP is embracing agile methodologies and the traditional separation into User <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW227108283 BCX4\">Requirements<\/span><span class=\"NormalTextRun SCXW227108283 BCX4\">,<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW227108283 BCX4\">Functional<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW227108283 BCX4\">requirements<\/span> <span class=\"NormalTextRun SCXW227108283 BCX4\">and other<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW227108283 BCX4\">requirements<\/span><span class=\"NormalTextRun SCXW227108283 BCX4\"> is no longer present in the guide. However, some things did not change. Bad <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW227108283 BCX4\">Requirements<\/span><span class=\"NormalTextRun SCXW227108283 BCX4\"> are still bad, whether expressed as user stories in a system or in a specification document. And bad <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW227108283 BCX4\">requirements<\/span> <span class=\"NormalTextRun SCXW227108283 BCX4\">are inevitably lead to systems that are not fit for purpoase and not meeting regulatory expectations.<\/span><\/span><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Oliver Herrmann (CEO and founder of QFINITY) and Frank Henrichmann (Senior Executive Consultant at QFINITY) will give two presentations at the Lounges in Karlsruhe. Oliver Herrmann will give a presentation on the topic GAMP\u00ae5 &#8211; 2nd Edition &#8211; Applying the Key Principles to enable Innovation The presentation will provide an introduction to the key principles [&hellip;]<\/p>\n","protected":false},"author":3,"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-8097","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>April 18, 2023 | Lounges in Karlsruhe<\/title>\n<meta name=\"description\" content=\"QFINITY &#187; April 18, 2023 | Lounges in Karlsruhe\" \/>\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\/april-18-2023-lounges-in-karlsruhe\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"April 18, 2023 | Lounges in Karlsruhe\" \/>\n<meta property=\"og:description\" content=\"QFINITY &#187; April 18, 2023 | Lounges in Karlsruhe\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/april-18-2023-lounges-in-karlsruhe\/\" \/>\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=\"2023-03-17T09:04:36+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-03-17T09:10:52+00:00\" \/>\n<meta name=\"author\" content=\"oherrmann\" \/>\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=\"oherrmann\" \/>\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\/april-18-2023-lounges-in-karlsruhe\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/q-finity.de\/en\/april-18-2023-lounges-in-karlsruhe\/\"},\"author\":{\"name\":\"oherrmann\",\"@id\":\"https:\/\/q-finity.de\/en\/#\/schema\/person\/fd7928b06a6ad0441bb2801c32012a09\"},\"headline\":\"April 18, 2023 | Lounges in Karlsruhe\",\"datePublished\":\"2023-03-17T09:04:36+00:00\",\"dateModified\":\"2023-03-17T09:10:52+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/q-finity.de\/en\/april-18-2023-lounges-in-karlsruhe\/\"},\"wordCount\":227,\"publisher\":{\"@id\":\"https:\/\/q-finity.de\/en\/#organization\"},\"articleSection\":[\"Meet Qfinity\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/q-finity.de\/en\/april-18-2023-lounges-in-karlsruhe\/\",\"url\":\"https:\/\/q-finity.de\/en\/april-18-2023-lounges-in-karlsruhe\/\",\"name\":\"April 18, 2023 | Lounges in Karlsruhe\",\"isPartOf\":{\"@id\":\"https:\/\/q-finity.de\/en\/#website\"},\"datePublished\":\"2023-03-17T09:04:36+00:00\",\"dateModified\":\"2023-03-17T09:10:52+00:00\",\"description\":\"QFINITY &#187; 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