{"id":57173,"date":"2022-05-27T12:07:39","date_gmt":"2022-05-27T10:07:39","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/documentacion-y-retencion-de-registros-gmp\/"},"modified":"2022-05-27T12:07:39","modified_gmt":"2022-05-27T10:07:39","slug":"documentacion-y-retencion-de-registros-gmp","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/es\/online-course\/documentacion-y-retencion-de-registros-gmp\/","title":{"rendered":"Documentaci\u00f3n y Retenci\u00f3n de Registros GMP"},"content":{"rendered":"<p>Un sistema de documentaci\u00f3n s\u00f3lido refleja los mecanismos de aseguramiento de la calidad empleados en una empresa de fabricaci\u00f3n farmac\u00e9utica. Este curso le introduce a los est\u00e1ndares de documentaci\u00f3n y mantenimiento de registros en consonancia con las GMP. Un sistema robusto de documentaci\u00f3n y registros proporciona un marco para observar el proceso de fabricaci\u00f3n a lo largo del tiempo de un vistazo. Esto es muy \u00fatil para realizar futuros cambios seg\u00fan sea necesario. Tambi\u00e9n se le presentar\u00e1 la gu\u00eda de la OMS sobre la buena gesti\u00f3n de datos y registros.   <\/p>\n<p>&nbsp;<\/p>\n<p>En este curso, ofrecemos una s\u00edntesis del tema a trav\u00e9s de una experiencia online interactiva. Este material fue elaborado por un equipo de Expertos en Asuntos Regulatorios con una Cualificaci\u00f3n de la Northeastern University, Boston, pilotado por un Miembro Senior capaz de articular la teor\u00eda con la pr\u00e1ctica. <\/p>\n<p>&nbsp;<\/p>\n<h3>Plan de estudios<\/h3>\n<p>&nbsp;<\/p>\n<p><strong>Introducci\u00f3n<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 1: \u00bfPor qu\u00e9 necesitamos documentaci\u00f3n y retenci\u00f3n de registros?<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 2: \u00bfCu\u00e1l es el alcance de la documentaci\u00f3n y retenci\u00f3n de registros GMP?<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 3: Papel del sistema de aseguramiento de la calidad en el control y la retenci\u00f3n de documentos GMP<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 4: Tipos de documentos GMP<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Documentos de tipo instrucci\u00f3n<\/li>\n<li>Documentos de tipo registro<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 5: Los requisitos armonizados de la documentaci\u00f3n y retenci\u00f3n de registros GMP<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>La gu\u00eda de la OMS sobre buenas pr\u00e1cticas de gesti\u00f3n de datos y registros<\/li>\n<li>Anexo 5: Buenas pr\u00e1cticas de gesti\u00f3n de datos y registros<\/li>\n<li>La gu\u00eda de la USFDA para la industria: Registros electr\u00f3nicos: Firmas electr\u00f3nicas: Alcance y aplicaci\u00f3n.<\/li>\n<li>Las directrices de la UE sobre buenas pr\u00e1cticas de fabricaci\u00f3n de medicamentos para uso humano y veterinario: Documentaci\u00f3n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Glosario<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Conclusi\u00f3n<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Cuestionario<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Un sistema de documentaci\u00f3n s\u00f3lido refleja los mecanismos de aseguramiento de la calidad empleados en una empresa de fabricaci\u00f3n farmac\u00e9utica. Este curso le introduce a los est\u00e1ndares de documentaci\u00f3n y mantenimiento de registros en consonancia con las GMP. Un sistema robusto de documentaci\u00f3n y registros proporciona un marco para observar el proceso de fabricaci\u00f3n a [&hellip;]<\/p>\n","protected":false},"featured_media":45194,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[265,271,269],"product_tag":[],"class_list":{"0":"post-57173","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-productos-farmaceuticos","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>Documentaci\u00f3n GMP: Curso Online y Certificaci\u00f3n<\/title>\n<meta name=\"description\" content=\"Curso Online y Certificaci\u00f3n de Documentaci\u00f3n y Retenci\u00f3n de Registros GMP. 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