{"id":17310,"date":"2026-10-09T19:43:08","date_gmt":"2026-10-09T17:43:08","guid":{"rendered":"https:\/\/q-finity.de\/akademie\/"},"modified":"2026-11-01T12:12:15","modified_gmt":"2026-11-01T11:12:15","slug":"academy","status":"publish","type":"page","link":"https:\/\/q-finity.de\/en\/academy\/","title":{"rendered":"H\u00b2 Digital Hive by QFINITY"},"content":{"rendered":"\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":3,"featured_media":17311,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-17310","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.5 (Yoast SEO v28.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>AI in GxP Training Program with Certificate | H\u00b2 Digital Hive by QFINITY<\/title>\n<meta name=\"description\" content=\"AI in GxP e-learning: 18 modules, four levels, three access options, confirmation or certificate for your AI Act Article 4 measures. Starts 1 Dec 2026.\" \/>\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\/academy\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AI in GxP Training Program with Certificate | H\u00b2 Digital Hive by QFINITY\" \/>\n<meta property=\"og:description\" content=\"AI in GxP e-learning: 18 modules, four levels, three access options, confirmation or certificate for your AI Act Article 4 measures. Starts 1 Dec 2026.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/academy\/\" \/>\n<meta property=\"og:site_name\" content=\"QFINITY\" \/>\n<meta property=\"article:modified_time\" content=\"2026-11-01T11:12:15+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/10\/akademie-hero-v8.jpg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:title\" content=\"H\u00b2 Digital Hive by QFINITY\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"12 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/\",\"name\":\"AI in GxP Training Program with Certificate | H\u00b2 Digital Hive by QFINITY\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/q-finity.de\\\/wp-content\\\/uploads\\\/2026\\\/10\\\/akademie-hero-v8.jpg\",\"datePublished\":\"2026-10-09T17:43:08+00:00\",\"dateModified\":\"2026-11-01T11:12:15+00:00\",\"description\":\"AI in GxP e-learning: 18 modules, four levels, three access options, confirmation or certificate for your AI Act Article 4 measures. Starts 1 Dec 2026.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/\"]}],\"mainEntity\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/#course\"}},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/#primaryimage\",\"url\":\"https:\\\/\\\/q-finity.de\\\/wp-content\\\/uploads\\\/2026\\\/10\\\/akademie-hero-v8.jpg\",\"contentUrl\":\"https:\\\/\\\/q-finity.de\\\/wp-content\\\/uploads\\\/2026\\\/10\\\/akademie-hero-v8.jpg\",\"width\":2560,\"height\":1440,\"caption\":\"AI in GxP training: H\u00b2 Academy by QFINITY, four levels leading to the goal\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/q-finity.de\\\/en\\\/home\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"H\u00b2 Digital Hive by QFINITY\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/\",\"name\":\"QFINITY\",\"description\":\"Qualit\u00e4tsmanagement &amp; - sicherung\",\"publisher\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/q-finity.de\\\/en\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#organization\",\"name\":\"QFINITY\u221e\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/mlsqau6zetur.i.optimole.com\\\/cb:frAi.c2d9\\\/w:512\\\/h:512\\\/q:mauto\\\/f:best\\\/https:\\\/\\\/q-finity.de\\\/wp-content\\\/uploads\\\/2021\\\/03\\\/cropped-cropped-signet_PAN_orange.png\",\"contentUrl\":\"https:\\\/\\\/mlsqau6zetur.i.optimole.com\\\/cb:frAi.c2d9\\\/w:512\\\/h:512\\\/q:mauto\\\/f:best\\\/https:\\\/\\\/q-finity.de\\\/wp-content\\\/uploads\\\/2021\\\/03\\\/cropped-cropped-signet_PAN_orange.png\",\"width\":512,\"height\":512,\"caption\":\"QFINITY\u221e\"},\"image\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.linkedin.com\\\/company\\\/q-finity-quality-management\\\/\",\"https:\\\/\\\/www.instagram.com\\\/qfinity_official\\\/\",\"https:\\\/\\\/www.wikidata.org\\\/wiki\\\/Q141257555\"],\"founder\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#founder\"}},{\"@type\":\"FAQPage\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/#faq\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Is AI training mandatory under the AI Act?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Article 4 of the AI Act, as amended by the Digital Omnibus (Regulation (EU) 2026\\\/1744), requires providers and deployers of AI systems to take measures that promote AI literacy among their staff. Article 4 does not require a particular certificate or a guarantee that every individual reaches a specific proficiency level. The measures must nevertheless take prior knowledge, the context of use and the people affected into account. Each access option can form part of such measures, documented by knowledge checks and a confirmation of completion or certificate.\"}},{\"@type\":\"Question\",\"name\":\"Does the program replace system-specific training?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"No. The draft Annex 11 revision provides for system-specific training for everyone working with computerized systems in GMP activities, matched to their tasks and access rights. The program creates a shared understanding of AI in GxP. Training on your specific system then builds on it.\"}},{\"@type\":\"Question\",\"name\":\"What AI training do staff in GxP environments need?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"More than AI basics. Anyone who uses or evaluates AI in GxP processes needs a shared understanding of intended use, risk management, governance, supplier assessment and validation, in QA, IT and the business alike. The Initiate level therefore lays that foundation for every role. The Develop, Standardize and Optimize levels deepen that knowledge, up to generative and agentic AI.\"}},{\"@type\":\"Question\",\"name\":\"How do participants demonstrate what they have learned?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Each module ends with a knowledge check. For Initiate and the leadership access option, we issue a confirmation of completion with a module list. The full program ends with a final assessment and the H\u00b2 Academy certificate. It does not carry any external certification. On request, companies receive a report on their participants' progress.\"}},{\"@type\":\"Question\",\"name\":\"How does AI training for GxP environments differ from general AI training?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"General AI training explains the technology and its limits. In GxP environments, regulated companies must also meet what the regulations require: qualified personnel under Annex 11, quality risk management, data integrity, supplier assessment and validation of the overall system. Along the way, the 18 modules follow the ISPE GAMP Guide on AI. The modules are also useful outside GxP, for example for obligations under the AI Act.\"}}],\"isPartOf\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/\"}},{\"@type\":\"Course\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/#course\",\"name\":\"AI in GxP Enablement Training Program\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/\",\"description\":\"The H\u00b2 Academy by QFINITY is an e-learning program for AI in GxP training with 18 modules on four levels, recorded by two trainers who have contributed to ISPE GAMP guides. Experts and teams in QA, IT and the business units across pharma and medtech learn the same terms and methods, at their own pace and with a knowledge check for each module. Three access options lead from the entry level through the leadership training to the full program with certificate.\",\"provider\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#organization\"},\"inLanguage\":\"en\",\"availableLanguage\":\"en\",\"teaches\":[\"Key Terms and Use Cases\",\"Ethical Principles and Trustworthy AI\",\"Leading AI in Life Sciences\",\"Foundational Artificial Intelligence Literacy\",\"Common Challenges of AI Adoption\",\"Development Approach and System Life Cycle\",\"Dual Impact of AI on CSV Activities\",\"Overview of the AI Regulatory Landscape\",\"Quality Risk Management\",\"Quality Management and the Role of Quality\",\"Data for AI in Life Sciences\",\"Specification, Verification and Documentation\",\"Roles, Responsibilities and Knowledge Management\",\"Infrastructure, Platforms and AI Cloud Services\",\"Cybersecurity in an AI Context\",\"Generative and Agentic AI\",\"European Artificial Intelligence Act\",\"Supplier Collaboration and Management\"],\"syllabusSections\":[{\"@type\":\"Syllabus\",\"name\":\"Initiate: foundations and key terms\",\"description\":\"Key Terms and Use Cases, Ethical Principles and Trustworthy AI, Leading AI in Life Sciences, Foundational Artificial Intelligence Literacy\"},{\"@type\":\"Syllabus\",\"name\":\"Develop: life cycle and regulation\",\"description\":\"Common Challenges of AI Adoption, Development Approach and System Life Cycle, Dual Impact of AI on CSV Activities, Overview of the AI Regulatory Landscape\"},{\"@type\":\"Syllabus\",\"name\":\"Standardize: quality, data, roles\",\"description\":\"Quality Risk Management, Quality Management and the Role of Quality, Data for AI in Life Sciences, Specification, Verification and Documentation, Roles, Responsibilities and Knowledge Management\"},{\"@type\":\"Syllabus\",\"name\":\"Optimize: operations, security, suppliers\",\"description\":\"Infrastructure, Platforms and AI Cloud Services, Cybersecurity in an AI Context, Generative and Agentic AI, European Artificial Intelligence Act, Supplier Collaboration and Management\"}],\"educationalCredentialAwarded\":{\"@type\":\"EducationalOccupationalCredential\",\"name\":\"Confirmation of completion or certificate, depending on the access option\",\"credentialCategory\":\"certificate\"},\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/\"},\"hasCourseInstance\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/#course-instance\"},\"offers\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/#offer\"}},{\"@type\":\"CourseInstance\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/#course-instance\",\"courseMode\":\"online\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/\",\"courseWorkload\":\"40-50 hours\",\"startDate\":\"2026-12-01\",\"inLanguage\":\"en\",\"instructor\":[{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#person-martin-heitmann\"},{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#founder\"}]},{\"@type\":\"Offer\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/#offer\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/\",\"price\":\"990\",\"priceCurrency\":\"EUR\",\"category\":\"Paid\",\"availability\":\"https:\\\/\\\/schema.org\\\/PreOrder\",\"eligibleCustomerType\":\"https:\\\/\\\/schema.org\\\/Business\",\"itemOffered\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/#course\"},\"availabilityStarts\":\"2026-12-01\",\"seller\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#organization\"},\"priceSpecification\":{\"@type\":\"UnitPriceSpecification\",\"price\":\"990\",\"priceCurrency\":\"EUR\",\"valueAddedTaxIncluded\":false}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#founder\",\"name\":\"Oliver Herrmann\",\"jobTitle\":\"Founder & CEO\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/\",\"worksFor\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#organization\"},\"sameAs\":[\"https:\\\/\\\/www.linkedin.com\\\/in\\\/olherrmann\\\/\",\"https:\\\/\\\/virtual.ispe.org\\\/b\\\/sp\\\/oliver-herrmann-4399\",\"https:\\\/\\\/www.wikidata.org\\\/wiki\\\/Q141257562\"],\"knowsAbout\":[\"GxP-Compliance\",\"Computer System Validation\",\"Computer Software Assurance\",\"Data Integrity\",\"ALCOA++\",\"AI Governance\",\"GAMP 5\"],\"image\":\"https:\\\/\\\/q-finity.de\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/oliver-herrmann-qfinity-ceo-scaled.jpg\",\"description\":\"Founder and CEO of QFINITY, GAMP Europe Chair, qualified GAMP 5 and GAMP Data Integrity trainer, GQMA auditor and international speaker. Co-author of several ISPE GAMP guides, including the GAMP 5 Guide (2nd Edition).\",\"memberOf\":{\"@type\":\"Organization\",\"name\":\"International Society for Pharmaceutical Engineering (ISPE)\",\"url\":\"https:\\\/\\\/ispe.org\"},\"hasCredential\":[{\"@type\":\"EducationalOccupationalCredential\",\"credentialCategory\":\"degree\",\"name\":\"Graduate Computer Scientist (Dipl.-Inf.)\"},{\"@type\":\"EducationalOccupationalCredential\",\"credentialCategory\":\"certification\",\"name\":\"Microsoft Certified Systems Engineer (MCSE)\"},{\"@type\":\"EducationalOccupationalCredential\",\"credentialCategory\":\"certification\",\"name\":\"SAFe (Scaled Agile Framework)\"}]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#person-martin-heitmann\",\"name\":\"Martin Heitmann\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/academy\\\/\",\"worksFor\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#organization\"},\"jobTitle\":\"Advisor on Digital Innovation, Quality and Compliance; Mathematician\",\"description\":\"Martin Heitmann works at the intersection of digitalization, quality and innovation in the regulated life sciences. As co-lead he helped shape the ISPE GAMP Guide: Artificial Intelligence, which covers AI-supported computerized systems over their life cycle. For his work on AI within ISPE, he received the 2026 Max Seales Yonker Member of the Year Award (EMEA).\",\"sameAs\":[\"https:\\\/\\\/www.linkedin.com\\\/in\\\/martin-heitmann-1a4aa71a3\\\/\",\"https:\\\/\\\/ispe.org\\\/people\\\/martin-heitmann\"],\"award\":\"ISPE Max Seales Yonker Member of the Year Award 2026, Europe, Middle East, Africa\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"AI in GxP Training Program with Certificate | H\u00b2 Digital Hive by QFINITY","description":"AI in GxP e-learning: 18 modules, four levels, three access options, confirmation or certificate for your AI Act Article 4 measures. Starts 1 Dec 2026.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/q-finity.de\/en\/academy\/","og_locale":"en_US","og_type":"article","og_title":"AI in GxP Training Program with Certificate | H\u00b2 Digital Hive by QFINITY","og_description":"AI in GxP e-learning: 18 modules, four levels, three access options, confirmation or certificate for your AI Act Article 4 measures. Starts 1 Dec 2026.","og_url":"https:\/\/q-finity.de\/en\/academy\/","og_site_name":"QFINITY","article_modified_time":"2026-11-01T11:12:15+00:00","og_image":[{"url":"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/10\/akademie-hero-v8.jpg","type":"","width":"","height":""}],"twitter_card":"summary_large_image","twitter_title":"H\u00b2 Digital Hive by QFINITY","twitter_misc":{"Est. reading time":"12 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/q-finity.de\/en\/academy\/","url":"https:\/\/q-finity.de\/en\/academy\/","name":"AI in GxP Training Program with Certificate | H\u00b2 Digital Hive by QFINITY","isPartOf":{"@id":"https:\/\/q-finity.de\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/q-finity.de\/en\/academy\/#primaryimage"},"image":{"@id":"https:\/\/q-finity.de\/en\/academy\/#primaryimage"},"thumbnailUrl":"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/10\/akademie-hero-v8.jpg","datePublished":"2026-10-09T17:43:08+00:00","dateModified":"2026-11-01T11:12:15+00:00","description":"AI in GxP e-learning: 18 modules, four levels, three access options, confirmation or certificate for your AI Act Article 4 measures. Starts 1 Dec 2026.","breadcrumb":{"@id":"https:\/\/q-finity.de\/en\/academy\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/q-finity.de\/en\/academy\/"]}],"mainEntity":{"@id":"https:\/\/q-finity.de\/en\/academy\/#course"}},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/q-finity.de\/en\/academy\/#primaryimage","url":"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/10\/akademie-hero-v8.jpg","contentUrl":"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/10\/akademie-hero-v8.jpg","width":2560,"height":1440,"caption":"AI in GxP training: H\u00b2 Academy by QFINITY, four levels leading to the goal"},{"@type":"BreadcrumbList","@id":"https:\/\/q-finity.de\/en\/academy\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/q-finity.de\/en\/home\/"},{"@type":"ListItem","position":2,"name":"H\u00b2 Digital Hive by QFINITY"}]},{"@type":"WebSite","@id":"https:\/\/q-finity.de\/en\/#website","url":"https:\/\/q-finity.de\/en\/","name":"QFINITY","description":"Qualit\u00e4tsmanagement &amp; - sicherung","publisher":{"@id":"https:\/\/q-finity.de\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/q-finity.de\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/q-finity.de\/en\/#organization","name":"QFINITY\u221e","url":"https:\/\/q-finity.de\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/q-finity.de\/en\/#\/schema\/logo\/image\/","url":"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:512\/h:512\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/cropped-cropped-signet_PAN_orange.png","contentUrl":"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:512\/h:512\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/cropped-cropped-signet_PAN_orange.png","width":512,"height":512,"caption":"QFINITY\u221e"},"image":{"@id":"https:\/\/q-finity.de\/en\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/q-finity-quality-management\/","https:\/\/www.instagram.com\/qfinity_official\/","https:\/\/www.wikidata.org\/wiki\/Q141257555"],"founder":{"@id":"https:\/\/q-finity.de\/en\/#founder"}},{"@type":"FAQPage","@id":"https:\/\/q-finity.de\/en\/academy\/#faq","mainEntity":[{"@type":"Question","name":"Is AI training mandatory under the AI Act?","acceptedAnswer":{"@type":"Answer","text":"Article 4 of the AI Act, as amended by the Digital Omnibus (Regulation (EU) 2026\/1744), requires providers and deployers of AI systems to take measures that promote AI literacy among their staff. Article 4 does not require a particular certificate or a guarantee that every individual reaches a specific proficiency level. The measures must nevertheless take prior knowledge, the context of use and the people affected into account. Each access option can form part of such measures, documented by knowledge checks and a confirmation of completion or certificate."}},{"@type":"Question","name":"Does the program replace system-specific training?","acceptedAnswer":{"@type":"Answer","text":"No. The draft Annex 11 revision provides for system-specific training for everyone working with computerized systems in GMP activities, matched to their tasks and access rights. The program creates a shared understanding of AI in GxP. Training on your specific system then builds on it."}},{"@type":"Question","name":"What AI training do staff in GxP environments need?","acceptedAnswer":{"@type":"Answer","text":"More than AI basics. Anyone who uses or evaluates AI in GxP processes needs a shared understanding of intended use, risk management, governance, supplier assessment and validation, in QA, IT and the business alike. The Initiate level therefore lays that foundation for every role. The Develop, Standardize and Optimize levels deepen that knowledge, up to generative and agentic AI."}},{"@type":"Question","name":"How do participants demonstrate what they have learned?","acceptedAnswer":{"@type":"Answer","text":"Each module ends with a knowledge check. For Initiate and the leadership access option, we issue a confirmation of completion with a module list. The full program ends with a final assessment and the H\u00b2 Academy certificate. It does not carry any external certification. On request, companies receive a report on their participants' progress."}},{"@type":"Question","name":"How does AI training for GxP environments differ from general AI training?","acceptedAnswer":{"@type":"Answer","text":"General AI training explains the technology and its limits. In GxP environments, regulated companies must also meet what the regulations require: qualified personnel under Annex 11, quality risk management, data integrity, supplier assessment and validation of the overall system. Along the way, the 18 modules follow the ISPE GAMP Guide on AI. The modules are also useful outside GxP, for example for obligations under the AI Act."}}],"isPartOf":{"@id":"https:\/\/q-finity.de\/en\/academy\/"}},{"@type":"Course","@id":"https:\/\/q-finity.de\/en\/academy\/#course","name":"AI in GxP Enablement Training Program","url":"https:\/\/q-finity.de\/en\/academy\/","description":"The H\u00b2 Academy by QFINITY is an e-learning program for AI in GxP training with 18 modules on four levels, recorded by two trainers who have contributed to ISPE GAMP guides. Experts and teams in QA, IT and the business units across pharma and medtech learn the same terms and methods, at their own pace and with a knowledge check for each module. Three access options lead from the entry level through the leadership training to the full program with certificate.","provider":{"@id":"https:\/\/q-finity.de\/en\/#organization"},"inLanguage":"en","availableLanguage":"en","teaches":["Key Terms and Use Cases","Ethical Principles and Trustworthy AI","Leading AI in Life Sciences","Foundational Artificial Intelligence Literacy","Common Challenges of AI Adoption","Development Approach and System Life Cycle","Dual Impact of AI on CSV Activities","Overview of the AI Regulatory Landscape","Quality Risk Management","Quality Management and the Role of Quality","Data for AI in Life Sciences","Specification, Verification and Documentation","Roles, Responsibilities and Knowledge Management","Infrastructure, Platforms and AI Cloud Services","Cybersecurity in an AI Context","Generative and Agentic AI","European Artificial Intelligence Act","Supplier Collaboration and Management"],"syllabusSections":[{"@type":"Syllabus","name":"Initiate: foundations and key terms","description":"Key Terms and Use Cases, Ethical Principles and Trustworthy AI, Leading AI in Life Sciences, Foundational Artificial Intelligence Literacy"},{"@type":"Syllabus","name":"Develop: life cycle and regulation","description":"Common Challenges of AI Adoption, Development Approach and System Life Cycle, Dual Impact of AI on CSV Activities, Overview of the AI Regulatory Landscape"},{"@type":"Syllabus","name":"Standardize: quality, data, roles","description":"Quality Risk Management, Quality Management and the Role of Quality, Data for AI in Life Sciences, Specification, Verification and Documentation, Roles, Responsibilities and Knowledge Management"},{"@type":"Syllabus","name":"Optimize: operations, security, suppliers","description":"Infrastructure, Platforms and AI Cloud Services, Cybersecurity in an AI Context, Generative and Agentic AI, European Artificial Intelligence Act, Supplier Collaboration and Management"}],"educationalCredentialAwarded":{"@type":"EducationalOccupationalCredential","name":"Confirmation of completion or certificate, depending on the access option","credentialCategory":"certificate"},"mainEntityOfPage":{"@id":"https:\/\/q-finity.de\/en\/academy\/"},"hasCourseInstance":{"@id":"https:\/\/q-finity.de\/en\/academy\/#course-instance"},"offers":{"@id":"https:\/\/q-finity.de\/en\/academy\/#offer"}},{"@type":"CourseInstance","@id":"https:\/\/q-finity.de\/en\/academy\/#course-instance","courseMode":"online","url":"https:\/\/q-finity.de\/en\/academy\/","courseWorkload":"40-50 hours","startDate":"2026-12-01","inLanguage":"en","instructor":[{"@id":"https:\/\/q-finity.de\/en\/#person-martin-heitmann"},{"@id":"https:\/\/q-finity.de\/en\/#founder"}]},{"@type":"Offer","@id":"https:\/\/q-finity.de\/en\/academy\/#offer","url":"https:\/\/q-finity.de\/en\/academy\/","price":"990","priceCurrency":"EUR","category":"Paid","availability":"https:\/\/schema.org\/PreOrder","eligibleCustomerType":"https:\/\/schema.org\/Business","itemOffered":{"@id":"https:\/\/q-finity.de\/en\/academy\/#course"},"availabilityStarts":"2026-12-01","seller":{"@id":"https:\/\/q-finity.de\/en\/#organization"},"priceSpecification":{"@type":"UnitPriceSpecification","price":"990","priceCurrency":"EUR","valueAddedTaxIncluded":false}},{"@type":"Person","@id":"https:\/\/q-finity.de\/en\/#founder","name":"Oliver Herrmann","jobTitle":"Founder & CEO","url":"https:\/\/q-finity.de\/en\/","worksFor":{"@id":"https:\/\/q-finity.de\/en\/#organization"},"sameAs":["https:\/\/www.linkedin.com\/in\/olherrmann\/","https:\/\/virtual.ispe.org\/b\/sp\/oliver-herrmann-4399","https:\/\/www.wikidata.org\/wiki\/Q141257562"],"knowsAbout":["GxP-Compliance","Computer System Validation","Computer Software Assurance","Data Integrity","ALCOA++","AI Governance","GAMP 5"],"image":"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/06\/oliver-herrmann-qfinity-ceo-scaled.jpg","description":"Founder and CEO of QFINITY, GAMP Europe Chair, qualified GAMP 5 and GAMP Data Integrity trainer, GQMA auditor and international speaker. Co-author of several ISPE GAMP guides, including the GAMP 5 Guide (2nd Edition).","memberOf":{"@type":"Organization","name":"International Society for Pharmaceutical Engineering (ISPE)","url":"https:\/\/ispe.org"},"hasCredential":[{"@type":"EducationalOccupationalCredential","credentialCategory":"degree","name":"Graduate Computer Scientist (Dipl.-Inf.)"},{"@type":"EducationalOccupationalCredential","credentialCategory":"certification","name":"Microsoft Certified Systems Engineer (MCSE)"},{"@type":"EducationalOccupationalCredential","credentialCategory":"certification","name":"SAFe (Scaled Agile Framework)"}]},{"@type":"Person","@id":"https:\/\/q-finity.de\/en\/#person-martin-heitmann","name":"Martin Heitmann","url":"https:\/\/q-finity.de\/en\/academy\/","worksFor":{"@id":"https:\/\/q-finity.de\/en\/#organization"},"jobTitle":"Advisor on Digital Innovation, Quality and Compliance; Mathematician","description":"Martin Heitmann works at the intersection of digitalization, quality and innovation in the regulated life sciences. As co-lead he helped shape the ISPE GAMP Guide: Artificial Intelligence, which covers AI-supported computerized systems over their life cycle. For his work on AI within ISPE, he received the 2026 Max Seales Yonker Member of the Year Award (EMEA).","sameAs":["https:\/\/www.linkedin.com\/in\/martin-heitmann-1a4aa71a3\/","https:\/\/ispe.org\/people\/martin-heitmann"],"award":"ISPE Max Seales Yonker Member of the Year Award 2026, Europe, Middle East, Africa"}]}},"_links":{"self":[{"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages\/17310","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/comments?post=17310"}],"version-history":[{"count":3,"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages\/17310\/revisions"}],"predecessor-version":[{"id":17416,"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages\/17310\/revisions\/17416"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/media\/17311"}],"wp:attachment":[{"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/media?parent=17310"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}