{"id":57679,"date":"2023-05-05T09:40:09","date_gmt":"2023-05-05T08:40:09","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/validacion-de-sistemas-informaticos-csv-y-gamp-5\/"},"modified":"2023-05-05T09:40:09","modified_gmt":"2023-05-05T07:40:09","slug":"validacion-de-sistemas-informaticos-csv-y-gamp-5","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/es\/online-course\/validacion-de-sistemas-informaticos-csv-y-gamp-5\/","title":{"rendered":"Validaci\u00f3n de Sistemas Inform\u00e1ticos (CSV) y GAMP 5"},"content":{"rendered":"<p>En entornos farmac\u00e9uticos regulados, un sistema informatizado no validado es un riesgo de cumplimiento. La <a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC11416705\/\">Validaci\u00f3n de Sistemas Inform\u00e1ticos<\/a> (CSV) es el proceso estructurado que demuestra que los sistemas funcionan de manera fiable, protegen la integridad de los datos y cumplen con las regulaciones, incluidas <a href=\"https:\/\/gxp-training.com\/es\/online-course\/introduccion-al-curso-online-fda-21-cfr-parte-11\/\">FDA 21 CFR Parte 11<\/a> 1 y <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2016-11\/annex11_01-2011_en_0.pdf\">Anexo 11 de la UE<\/a>. Este curso introduce el ciclo de vida de CSV y el enfoque basado en riesgos de GAMP 5 para la clasificaci\u00f3n de sistemas y la planificaci\u00f3n de la validaci\u00f3n. <\/p>\n<p>Tras completarlo con \u00e9xito, recibir\u00e1 un <strong>certificado validado acreditado con cr\u00e9ditos CPD\/CEU<\/strong>, adecuado para auditor\u00edas y documentaci\u00f3n de cumplimiento.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>\u00bfQui\u00e9n deber\u00eda inscribirse?<\/strong><\/p>\n<ul>\n<li>Profesionales de <a href=\"https:\/\/gxp-training.com\/es\/gxp-courses\/garantia-de-calidad\/\">aseguramiento de la calidad<\/a> y validaci\u00f3n<\/li>\n<li>Especialistas de TI y sistemas en empresas <a href=\"https:\/\/gxp-training.com\/es\/gxp-courses\/productos-farmaceuticos\/\">farmac\u00e9uticas<\/a> y biotecnol\u00f3gicas<\/li>\n<li>Personal de asuntos regulatorios que supervisa sistemas informatizados<\/li>\n<li>Gestores de proyectos involucrados en la implementaci\u00f3n y validaci\u00f3n de sistemas<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong style=\"font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', Arial, 'Noto Sans', sans-serif, 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Noto Color Emoji'\">\u00bfQu\u00e9 aprender\u00e1?<\/strong><\/p>\n<ul>\n<li>Importancia y funci\u00f3n de CSV en industrias reguladas<\/li>\n<li>Fases clave del ciclo de vida de CSV: concepto, proyecto, operaci\u00f3n, retirada<\/li>\n<li>Mejores pr\u00e1cticas para la planificaci\u00f3n de la validaci\u00f3n, documentaci\u00f3n y aseguramiento de la calidad<\/li>\n<li>Clasificaci\u00f3n de componentes de software y hardware seg\u00fan las directrices GAMP\u00ae5<\/li>\n<li>Desarrollo y uso de documentos de validaci\u00f3n esenciales como CDS y planes de validaci\u00f3n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3>Plan de estudios:<\/h3>\n<p><strong>Introducci\u00f3n<\/strong><br \/>\n<strong>Lecci\u00f3n 1: Introducci\u00f3n a las Directrices GAMP 5 para CSV<\/strong><br \/>\n<strong>Lecci\u00f3n 2: Proceso de Validaci\u00f3n en CSV<\/strong><br \/>\n<strong>Lecci\u00f3n 3: Fase 1 de CSV &#8211; Fase de Concepto<\/strong><br \/>\n<strong>Lecci\u00f3n 4: Fase 2 de CSV &#8211; Fase de Proyecto<\/strong><br \/>\n<strong>Lecci\u00f3n 5: Fase 3 de CSV &#8211; Fase de Operaci\u00f3n<\/strong><br \/>\n<strong>Lecci\u00f3n 6: Fase 4 de CSV &#8211; Fase de Retirada<\/strong><br \/>\n<strong>Lecci\u00f3n 7: Multifase y Lista de Verificaci\u00f3n para CSV<\/strong><br \/>\n<strong>Glosario<\/strong><br \/>\n<strong>Evaluaci\u00f3n<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>En entornos farmac\u00e9uticos regulados, un sistema informatizado no validado es un riesgo de cumplimiento. La Validaci\u00f3n de Sistemas Inform\u00e1ticos (CSV) es el proceso estructurado que demuestra que los sistemas funcionan de manera fiable, protegen la integridad de los datos y cumplen con las regulaciones, incluidas FDA 21 CFR Parte 11 1 y Anexo 11 de [&hellip;]<\/p>\n","protected":false},"featured_media":43909,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[265,271,275,278,273,272,270,269,266],"product_tag":[],"class_list":{"0":"post-57679","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-bpf-buenas-practicas-de-fabricacion","7":"product_cat-garantia-de-calidad","8":"product_cat-gcp-ensayos-clinicos","9":"product_cat-glp-buenas-practicas-de-laboratorio","10":"product_cat-intersectorial","11":"product_cat-laboratorios","12":"product_cat-organizacion-de-investigacion-por-contrato-cro","13":"product_cat-productos-farmaceuticos","14":"product_cat-productos-sanitarios","16":"first","17":"instock","18":"taxable","19":"shipping-taxable","20":"purchasable","21":"product-type-subscription"},"bundled_by":[],"bundle_stock_status":"instock","bundle_stock_quantity":null,"bundle_virtual":false,"bundle_layout":"","bundle_add_to_cart_form_location":"","bundle_editable_in_cart":false,"bundle_sold_individually_context":"","bundle_item_grouping":"","bundle_min_size":"","bundle_max_size":"","bundle_price":[],"bundled_items":[],"bundle_sell_ids":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Curso Online y Certificaci\u00f3n en Validaci\u00f3n de Sistemas Inform\u00e1ticos (CSV)<\/title>\n<meta name=\"description\" content=\"Aprenda CSV y GAMP 5 en este curso certificado online para ciencias de la vida. 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