{"id":57737,"date":"2023-01-02T12:51:28","date_gmt":"2023-01-02T12:51:28","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/gmp-para-dispositivos-medicos-ue-frente-a-fda\/"},"modified":"2023-01-02T12:51:28","modified_gmt":"2023-01-02T11:51:28","slug":"gmp-para-dispositivos-medicos-ue-frente-a-fda","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/es\/online-course\/gmp-para-dispositivos-medicos-ue-frente-a-fda\/","title":{"rendered":"GMP para dispositivos m\u00e9dicos: UE frente a FDA"},"content":{"rendered":"<p>La industria de los dispositivos m\u00e9dicos cuenta con sistemas de calidad integrados basados en las <a href=\"https:\/\/gxp-training.com\/es\/gxp-courses\/bpf-buenas-practicas-de-fabricacion\/\">Buenas Pr\u00e1cticas de Fabricaci\u00f3n<\/a> o GMP. Los organismos reguladores que rigen estos sistemas son diferentes en la UE y en EE. UU. En EE. UU., el Center for Devices and Radiological Health (CDRG), de la FDA, regula principalmente los dispositivos m\u00e9dicos y la propia FDA realiza todas las inspecciones regulatorias. La FDA de EE. UU. tambi\u00e9n ha establecido requisitos de cumplimiento de GMP para el desarrollo, la fabricaci\u00f3n y la distribuci\u00f3n de dispositivos m\u00e9dicos en el Code of Federal Regulations:<a href=\"https:\/\/gxp-training.com\/es\/online-course\/bpf-para-productos-sanitarios-y-fda-21-cfr-parte-820\/\"> 21 CFR, Parte 820<\/a>.   <\/p>\n<div class=\"noOutline\" data-ba-index=\"5\" data-ba=\"lessonEdit.block\" data-block-id=\"cl9phdl4900cu286ddag8srng\">\n<div class=\"block-image block-image--text-aside block-image--legacy \" data-ba=\"blocks.blockImage\">\n<div class=\"block-image__container\">\n<div class=\"block-image__row\">\n<div class=\"block-image__col\">\n<div class=\"block-image__text brand--body brand--linkColor brand--linkColor\">\n<div class=\"fr-view\">\n<p>En este curso, ofrecemos una s\u00edntesis comparativa del tema a trav\u00e9s de una experiencia online interactiva. Se aplica a todas las \u00e1reas de las GMP para dispositivos m\u00e9dicos y proporciona una formaci\u00f3n adecuada en gesti\u00f3n de la calidad y cumplimiento de GMP en la industria de fabricaci\u00f3n de dispositivos m\u00e9dicos. Este material ha sido elaborado por un equipo de expertos en Asuntos Regulatorios con una titulaci\u00f3n de Northeastern University, Boston, y pilotado por un miembro s\u00e9nior capaz de articular la teor\u00eda con la pr\u00e1ctica.  <\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<h3>Programa:<\/h3>\n<p>&nbsp;<\/p>\n<p><strong>Introducci\u00f3n<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 1: Diferencias entre los requisitos GMP de la UE y la FDA<\/strong><\/p>\n<ul>\n<li>Principales requisitos europeos<\/li>\n<li>Principales requisitos de la FDA<\/li>\n<li>Diferencias<\/li>\n<li>Similitudes<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 2: Requisitos relacionados con GMP de la EN ISO 13485:2016<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 3: Requisitos GMP de la FDA en <a href=\"https:\/\/gxp-training.com\/es\/online-course\/bpf-para-productos-sanitarios-y-fda-21-cfr-parte-820\/\">21 CFR Parte 820<\/a><\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 4: Controles de dise\u00f1o de dispositivos m\u00e9dicos<\/strong><\/p>\n<ul>\n<li>C\u00f3mo implementar los controles de dise\u00f1o en el proceso del ciclo de vida<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 5: Validaci\u00f3n de procesos<\/strong><\/p>\n<ul>\n<li>Requisitos de la FDA para la validaci\u00f3n de procesos<\/li>\n<li>\u00bfQu\u00e9 son los <a href=\"https:\/\/gxp-training.com\/es\/online-course\/ensayos-clinicos-preparacion-para-una-auditoria-o-una-inspeccion\/\">ensayos cl\u00ednicos<\/a>?<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 6: Gesti\u00f3n de reclamaciones (<a href=\"https:\/\/gxp-training.com\/es\/online-course\/formacion-en-acciones-correctivas-y-preventivas-capa\/\">Acci\u00f3n Correctiva y Preventiva<\/a>)<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Glosario<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Evaluaci\u00f3n<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La industria de los dispositivos m\u00e9dicos cuenta con sistemas de calidad integrados basados en las Buenas Pr\u00e1cticas de Fabricaci\u00f3n o GMP. Los organismos reguladores que rigen estos sistemas son diferentes en la UE y en EE. UU. En EE. UU., el Center for Devices and Radiological Health (CDRG), de la FDA, regula principalmente los dispositivos [&hellip;]<\/p>\n","protected":false},"featured_media":43291,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[276,265,266],"product_tag":[],"class_list":{"0":"post-57737","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-productos-sanitarios","10":"first","11":"instock","12":"taxable","13":"shipping-taxable","14":"purchasable","15":"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>GMP para dispositivos m\u00e9dicos: UE vs FDA - Curso y certificaci\u00f3n<\/title>\n<meta name=\"description\" content=\"GMP para dispositivos m\u00e9dicos, diferencias entre EE. 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