{"id":57167,"date":"2022-05-27T12:11:18","date_gmt":"2022-05-27T10:11:18","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/introduccion-al-curso-online-fda-21-cfr-parte-11\/"},"modified":"2022-05-27T12:11:18","modified_gmt":"2022-05-27T10:11:18","slug":"introduccion-al-curso-online-fda-21-cfr-parte-11","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/es\/online-course\/introduccion-al-curso-online-fda-21-cfr-parte-11\/","title":{"rendered":"Introducci\u00f3n al Curso Online FDA 21 CFR PARTE 11"},"content":{"rendered":"
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Los objetivos principales de este curso e-learning son proporcionar a los alumnos una base s\u00f3lida en los principios y los \u00faltimos requisitos para los Registros Electr\u00f3nicos seg\u00fan la FDA 21 CFR PARTE 11. La formaci\u00f3n ofrece una visi\u00f3n general de los requisitos de la FDA con ejemplos pr\u00e1cticos que cubren la implementaci\u00f3n de dichos requisitos. El curso abarca la aplicaci\u00f3n de estos requisitos tanto a los sistemas de hardware como de software utilizados en Fabricaci\u00f3n<\/a>, QA, Regulaci\u00f3n, validaci\u00f3n y Control de Procesos. <\/p>\n<\/div>\n

En este curso, ofrecemos una s\u00edntesis sobre el tema a trav\u00e9s de una experiencia online interactiva. Este material fue elaborado por un equipo de Expertos en Asuntos Regulatorios con cualificaci\u00f3n de la Northeastern University, Boston, y pilotado por un Miembro Senior capaz de articular la teor\u00eda con la pr\u00e1ctica. <\/span><\/p>\n

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 <\/p>\n<\/div>\n<\/div>\n<\/div>\n

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Plan de estudios:<\/h2>\n<\/div>\n

Introducci\u00f3n<\/strong><\/p>\n

M\u00f3dulo 1: Las Normas Predicadas<\/strong><\/p>\n

    \n
  • 21 CFR Parte 11 explicado<\/li>\n
  • Registros electr\u00f3nicos<\/li>\n
  • \u00bfQu\u00e9 son las normas predicadas?<\/li>\n
  • Relaci\u00f3n con las normas predicadas<\/li>\n
  • Normas predicadas y registros de lote<\/li>\n
  • Firmas electr\u00f3nicas<\/li>\n
  • Firmas manuscritas<\/li>\n<\/ul>\n

    M\u00f3dulo 2: \u00bfQu\u00e9 es la Parte 11?<\/strong><\/p>\n

      \n
    • \u00bfQu\u00e9 es la 21 CFR Parte 11?<\/li>\n
    • Directriz<\/li>\n
    • Alcance y aplicaci\u00f3n limitados de la Parte 11<\/li>\n
    • Los beneficios<\/li>\n<\/ul>\n

      M\u00f3dulo 3: Firmas y Registros Electr\u00f3nicos Explicados<\/strong><\/p>\n

        \n
      • Firmas electr\u00f3nicas no afectadas<\/li>\n<\/ul>\n

         <\/p>\n

        Conclusi\u00f3n<\/strong><\/p>\n

        Examen Final<\/strong><\/p>\n

        Certificaci\u00f3n<\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

        Los objetivos principales de este curso e-learning son proporcionar a los alumnos una base s\u00f3lida en los principios y los \u00faltimos requisitos para los Registros Electr\u00f3nicos seg\u00fan la FDA 21 CFR PARTE 11. La formaci\u00f3n ofrece una visi\u00f3n general de los requisitos de la FDA con ejemplos pr\u00e1cticos que cubren la implementaci\u00f3n de dichos requisitos. […]<\/p>\n","protected":false},"featured_media":42859,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[265,271,275,278,279,273,272,270,269,266],"product_tag":[],"class_list":{"0":"post-57167","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-hospitales-e-instituciones-sanitarias","11":"product_cat-intersectorial","12":"product_cat-laboratorios","13":"product_cat-organizacion-de-investigacion-por-contrato-cro","14":"product_cat-productos-farmaceuticos","15":"product_cat-productos-sanitarios","17":"first","18":"instock","19":"taxable","20":"shipping-taxable","21":"purchasable","22":"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":"\nCursos Online y Certificaci\u00f3n FDA 21 CFR PARTE 11<\/title>\n<meta name=\"description\" content=\"Curso online FDA 21 CFR PARTE 11 con certificaci\u00f3n. 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