{"id":57762,"date":"2022-12-06T14:46:47","date_gmt":"2022-12-06T14:46:47","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/integridad-de-datos-farmaceuticos-alcoa-y-alcoa\/"},"modified":"2022-12-06T14:46:47","modified_gmt":"2022-12-06T13:46:47","slug":"integridad-de-datos-farmaceuticos-alcoa-y-alcoa","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/es\/online-course\/integridad-de-datos-farmaceuticos-alcoa-y-alcoa\/","title":{"rendered":"Integridad de Datos Farmac\u00e9uticos: ALCOA y ALCOA+"},"content":{"rendered":"<p>Los registros incompletos, inconsistentes o no rastreables se encuentran entre los hallazgos m\u00e1s citados en las inspecciones farmac\u00e9uticas. Este curso aborda la ra\u00edz de ese riesgo, cubriendo los principios ALCOA y ALCOA+ que la FDA, la OMS y la MHRA esperan que las organizaciones apliquen a cada registro, sistema y proceso a lo largo del ciclo de vida del producto. <\/p>\n<p><strong>\u00bfQu\u00e9 aprender\u00e1?<\/strong><\/p>\n<ul>\n<li>Principios de integridad de datos y expectativas regulatorias (<a href=\"https:\/\/www.fda.gov\/\">FDA<\/a>, <a href=\"https:\/\/www.who.int\/\">OMS<\/a>, MHRA)<\/li>\n<li>Aplicar los principios ALCOA y ALCOA+ para garantizar registros conformes<\/li>\n<li>Identificar y prevenir violaciones comunes de integridad de datos<\/li>\n<li>Garantizar la integridad de datos en sistemas basados en papel y sistemas informatizados<\/li>\n<\/ul>\n<p><strong>\u00bfQui\u00e9n deber\u00eda inscribirse?<\/strong><\/p>\n<ul>\n<li>Profesionales de aseguramiento de la calidad y control de calidad<\/li>\n<li>Personal de <a href=\"https:\/\/gxp-training.com\/es\/gxp-courses\/bpf-buenas-practicas-de-fabricacion\/\">fabricaci\u00f3n<\/a>, producci\u00f3n y laboratorio<\/li>\n<li>Especialistas en <a href=\"https:\/\/gxp-training.com\/online-course\/regulatory-affairs-specialist-training-certification\/\">asuntos regulatorios<\/a> y cumplimiento normativo<\/li>\n<li>Profesionales responsables de la <a href=\"https:\/\/www.fda.gov\/drugs\/pharmaceutical-quality-resources\/current-good-manufacturing-practice-cgmp-regulations\">documentaci\u00f3n GMP<\/a> y gesti\u00f3n de datos<\/li>\n<\/ul>\n<p>Tras completar con \u00e9xito el curso, recibir\u00e1 un <strong>certificado validado acreditado con cr\u00e9ditos CPD\/CEU<\/strong>, adecuado para auditor\u00edas y documentaci\u00f3n de cumplimiento.<\/p>\n<h3>Programa:<\/h3>\n<p><strong>Introducci\u00f3n<\/strong><\/p>\n<ul>\n<li>\u00bfPor qu\u00e9 es importante la integridad de datos en la industria farmac\u00e9utica?<\/li>\n<li>\u00bfQui\u00e9n es responsable de garantizar la integridad de datos?<\/li>\n<\/ul>\n<p><strong>Lecci\u00f3n 1: Descripci\u00f3n general de las directrices sobre integridad de datos<\/strong><\/p>\n<p><strong>Lecci\u00f3n 2: Principios de integridad de datos<\/strong><\/p>\n<p><strong>Lecci\u00f3n 3<\/strong>: <strong>Principios ALCOA para la integridad de datos<\/strong><\/p>\n<p><strong>Lecci\u00f3n 4<\/strong>: <strong>Violaciones de integridad de datos<\/strong><\/p>\n<ul>\n<li>Problemas comunes<\/li>\n<li>Abordaje de violaciones<\/li>\n<\/ul>\n<p><strong>Lecci\u00f3n 5<\/strong>: <strong>\u00bfC\u00f3mo asegurar la integridad de datos?<\/strong><\/p>\n<ul>\n<li>Cultura de calidad<\/li>\n<li>Gesti\u00f3n del ciclo de vida de los datos<\/li>\n<\/ul>\n<p><strong>Lecci\u00f3n 6<\/strong>: <strong>Integridad de datos para sistemas basados en papel<\/strong><\/p>\n<p><strong>Lecci\u00f3n 7<\/strong>: <strong>Integridad de datos para sistemas informatizados<\/strong><\/p>\n<p><strong>Lecci\u00f3n 8<\/strong>: <strong>Papel del sistema de calidad en la integridad de datos<\/strong><\/p>\n<p><strong>Conclusi\u00f3n<\/strong><\/p>\n<p><strong>Glosario<\/strong><\/p>\n<p><strong>Cuestionario<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Los registros incompletos, inconsistentes o no rastreables se encuentran entre los hallazgos m\u00e1s citados en las inspecciones farmac\u00e9uticas. Este curso aborda la ra\u00edz de ese riesgo, cubriendo los principios ALCOA y ALCOA+ que la FDA, la OMS y la MHRA esperan que las organizaciones apliquen a cada registro, sistema y proceso a lo largo del [&hellip;]<\/p>\n","protected":false},"featured_media":43199,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[276,265,268,272,270,269],"product_tag":[],"class_list":{"0":"post-57762","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-asuntos-regulatorios","7":"product_cat-bpf-buenas-practicas-de-fabricacion","8":"product_cat-farmacovigilancia","9":"product_cat-laboratorios","10":"product_cat-organizacion-de-investigacion-por-contrato-cro","11":"product_cat-productos-farmaceuticos","13":"first","14":"instock","15":"taxable","16":"shipping-taxable","17":"purchasable","18":"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>Integridad de Datos Farmac\u00e9uticos: Curso Online ALCOA \/ ALCOA+<\/title>\n<meta name=\"description\" content=\"Curso Online Certificado de Integridad de Datos Farmac\u00e9uticos. 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