{"id":4473,"date":"2023-05-30T16:26:28","date_gmt":"2023-05-30T14:26:28","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/?post_type=product&#038;p=4473"},"modified":"2026-07-09T12:05:37","modified_gmt":"2026-07-09T10:05:37","slug":"data-integrity-compliance-computer-systems-validation","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/pharma-engineering-and-validation\/data-integrity-compliance-computer-systems-validation\/","title":{"rendered":"Data Integrity &#038; Computer Systems Validation (CSV): comprendere le attuali aspettative regolatorie"},"content":{"rendered":"<div class=\"et_pb_row_inner et_pb_row_inner_1\">\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_inner et_pb_column_inner_2 et-last-child\">\n<div class=\"et_pb_module et_pb_text et_pb_text_1 et_pb_text_align_justified et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<p>Partendo dalla presentazione dei failures pi\u00f9 significativi in ambito Data Integrity, saranno presentate le aspettative delle agenzie ispettive in materia Systems Compliance e Data Integrity. Verranno presentate tecniche di self-assessment per valutare il livello di compliance della propria realt\u00e0 produttiva, fornendo esempi di gaps e relative azioni mitiganti e correttive. Infine, saranno presentati le modalit\u00e0 per eseguire la Computer System Validation, la Qualifica dell\u2019Infrastruttura IT e per il mantenimento dello stato di convalida per assicurare una corretta gestione dei dati aventi impatto sulla qualit\u00e0 dei processi. Focus rilevante sar\u00e0 dedicato alle novit\u00e0 introdotte dalla ultima release della GAMP5.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Partendo dalla presentazione dei failures pi\u00f9 significativi in ambito Data Integrity, saranno presentate le aspettative delle agenzie ispettive in materia Systems Compliance e Data Integrity, anche sulla base del nuovo GAMP 5.<\/p>\n","protected":false},"featured_media":4465,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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del corso<\/h5>\r\n09:30 \u2013 12:30 SESSIONE MATTINA\r\n14:00 \u2013 17:00 SESSIONE POMERIGGIO\r\n\r\n<strong>Regulatory Requirements and Expectations\r\n<\/strong>- Regulatory Trends in Data Integrity and Validation\r\n- Overview di recenti Warning letters\r\n<em>10.45 \u2013 11.00 Coffee Break<\/em>\r\n\r\n<strong>Validation Standards\r\n<\/strong>- GAMP5: Design of a new Computerized System\r\n- IT Infrastructure Layer and Regulatory Expectations\r\n<em>12.30 \u2013 14.00 LUNCH <\/em>\r\n\r\n<strong>Validation Practices\r\n<\/strong>- Compliance Assessment Strategy\r\n- How to select System Suppliers for Data Integrity Assurance\r\n- Software Validation (Best Practices)\r\n- Operational Processes\r\n<em>15.30 \u2013 15.45 Coffee Break<\/em>\r\n\r\n<strong>Case studies\r\n<\/strong>- Upgrade of a LAS (prospective validation)\r\n- Cyber attack management (Disaster Recovery)\r\n- LIMS Integration and Validation\r\n- Paperless Manufacturing\r\n- ERP\/MES\/EBR\/SCADA Implementation 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et-pb-active-slide\">\r\n<div class=\"et_pb_tab_content\">\r\n\r\nQA Manager e Specialist, QC \u2013 Resp. Laboratorio, QP, Validation Manager, Production Manager, IT Manager.\r\n\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>","corso_competenze":[{"corso_competenze_item":"Acquisire confidenza con gli attuali requisiti normativi sull'integrit\u00e0 dei dati e come gli enti regolatori interpretano tali requisiti"},{"corso_competenze_item":"Comprendere le aspettative delle agenzie regolatorie nei confronti delle aziende farmaceutiche in merito all'integrit\u00e0 dei dati"},{"corso_competenze_item":"Integrare i requisiti normativi sull'integrit\u00e0 dei dati nel sistema di qualit\u00e0 aziendale per definire un efficace sistema di Data Governance"},{"corso_competenze_item":"Valutare preventivamente lo stato di compliance dei dati aventi impatto sulla qualit\u00e0"},{"corso_competenze_item":"Preparare l\u2019azienda per un'ispezione di successo in merito all'integrit\u00e0 dei dati"},{"corso_competenze_item":"Definire una strategia di validazione dei sistemi computerizzati efficace e sostenibile per l\u2019azienda"}]},"_links":{"self":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product\/4473","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/types\/product"}],"wp:attachment":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media?parent=4473"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_brand?post=4473"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_cat?post=4473"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_tag?post=4473"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}