{"id":57352,"date":"2022-05-24T10:10:54","date_gmt":"2022-05-24T08:10:54","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/vision-general-de-la-cualificacion-y-la-validacion\/"},"modified":"2022-05-24T10:10:54","modified_gmt":"2022-05-24T08:10:54","slug":"vision-general-de-la-cualificacion-y-la-validacion","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/es\/online-course\/vision-general-de-la-cualificacion-y-la-validacion\/","title":{"rendered":"Visi\u00f3n general de la cualificaci\u00f3n y la validaci\u00f3n"},"content":{"rendered":"<p>En la fabricaci\u00f3n <a href=\"https:\/\/gxp-training.com\/es\/gxp-courses\/productos-farmaceuticos\/\">farmac\u00e9utica<\/a> y de <a href=\"https:\/\/gxp-training.com\/es\/gxp-courses\/productos-sanitarios\/\">productos sanitarios<\/a>, la calidad del producto y la seguridad del paciente no son objetivos aspiracionales, sino <a href=\"https:\/\/www.fda.gov\/drugs\/pharmaceutical-quality-resources\/current-good-manufacturing-practice-cgmp-regulations\">requisitos regulatorios<\/a>. Este curso introductorio cubre los principios fundamentales de la cualificaci\u00f3n y la validaci\u00f3n dentro del marco de las <a href=\"https:\/\/gxp-training.com\/online-course\/cfrs-part-210-and-211-online-certified-course-training\/\">Normas de Correcta Fabricaci\u00f3n<\/a> cGMP vigentes. <\/p>\n<p>Una vez completado con \u00e9xito, recibir\u00e1 un <strong>certificado validado acreditado con cr\u00e9ditos CPD\/CEU<\/strong>, reconocido para fines de auditor\u00eda y cumplimiento normativo.<\/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\/\">garant\u00eda de calidad<\/a> y control de calidad<\/li>\n<li>Personal de fabricaci\u00f3n e ingenier\u00eda de procesos<\/li>\n<li>Profesionales de <a href=\"https:\/\/gxp-training.com\/es\/gxp-courses\/asuntos-regulatorios\/\">asuntos regulatorios<\/a><\/li>\n<li>Profesionales nuevos en validaci\u00f3n que buscan una visi\u00f3n general estructurada y fundamental<\/li>\n<\/ul>\n<p><strong>\u00bfQu\u00e9 aprender\u00e1?<\/strong><\/p>\n<ul>\n<li>La definici\u00f3n y los principios fundamentales de la validaci\u00f3n dentro del marco cGMP<\/li>\n<li>Tipos clave de validaci\u00f3n: prospectiva, concurrente, retrospectiva y revalidaci\u00f3n<\/li>\n<li>La estructura y el prop\u00f3sito de un Plan Maestro de Validaci\u00f3n (VMP)<\/li>\n<li>Las tres etapas de la <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/process-validation-general-principles-and-practices\">validaci\u00f3n de procesos<\/a>: dise\u00f1o, cualificaci\u00f3n y verificaci\u00f3n<\/li>\n<li>Requisitos de validaci\u00f3n para limpieza, sistemas inform\u00e1ticos y m\u00e9todos anal\u00edticos<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3>Programa<\/h3>\n<p><strong>Introducci\u00f3n<\/strong><\/p>\n<p><strong>Lecci\u00f3n 1: Definici\u00f3n de validaci\u00f3n<\/strong><\/p>\n<p><strong>Lecci\u00f3n 2: Necesidad de cualificaci\u00f3n y validaci\u00f3n de procesos<\/strong><\/p>\n<p><strong>Lecci\u00f3n 3: Alcance de la validaci\u00f3n<\/strong><\/p>\n<ul>\n<li>Importancia de la validaci\u00f3n<\/li>\n<\/ul>\n<p><strong>Lecci\u00f3n 4: Principales ventajas de la validaci\u00f3n<\/strong><\/p>\n<ul>\n<li>Garant\u00eda de calidad<\/li>\n<li>Optimizaci\u00f3n de procesos<\/li>\n<li>Reducci\u00f3n de costes de calidad<\/li>\n<\/ul>\n<p><strong>Lecci\u00f3n 5: Tipos\/m\u00e9todos de validaci\u00f3n<\/strong><\/p>\n<ul>\n<li>Validaci\u00f3n prospectiva<\/li>\n<li>Validaci\u00f3n concurrente<\/li>\n<li>Validaci\u00f3n retrospectiva<\/li>\n<\/ul>\n<p><strong>Lecci\u00f3n 6: Actividades a realizar antes de iniciar un proyecto de validaci\u00f3n<\/strong><\/p>\n<ul>\n<li>El Comit\u00e9 de Validaci\u00f3n<\/li>\n<li>Evaluaci\u00f3n de procesos para determinar los requisitos de validaci\u00f3n<\/li>\n<li>Identificaci\u00f3n de sistemas y l\u00edmites del sistema<\/li>\n<\/ul>\n<p><strong>Lecci\u00f3n 7: Plan Maestro de Validaci\u00f3n<\/strong><\/p>\n<ul>\n<li>Plan Maestro de Validaci\u00f3n<\/li>\n<li>Contenido del VMP<\/li>\n<\/ul>\n<p><strong>Lecci\u00f3n 8: Concepto b\u00e1sico de validaci\u00f3n de procesos<\/strong><\/p>\n<ul>\n<li>Cualificaci\u00f3n de la instalaci\u00f3n (IQ)<\/li>\n<li>Cualificaci\u00f3n operacional (OQ)<\/li>\n<li>Cualificaci\u00f3n del desempe\u00f1o (PQ)<\/li>\n<\/ul>\n<p><strong>Lecci\u00f3n 9: Las etapas de la validaci\u00f3n de procesos<\/strong><\/p>\n<ul>\n<li>Etapa 1 \u2013 Dise\u00f1o del proceso<\/li>\n<li>Etapa 2 \u2013 Validaci\u00f3n del proceso o cualificaci\u00f3n del proceso<\/li>\n<li>Etapa 3 \u2013 Verificaci\u00f3n continua del proceso<\/li>\n<\/ul>\n<p><strong>Lecci\u00f3n 10: Informe del protocolo de validaci\u00f3n<\/strong><\/p>\n<p><strong>Lecci\u00f3n 11: <a href=\"https:\/\/gxp-training.com\/online-course\/cleaning-validation-course\/\">Validaci\u00f3n de limpieza<\/a><\/strong><\/p>\n<ul>\n<li>Elecci\u00f3n del m\u00e9todo de limpieza<\/li>\n<li>Medici\u00f3n del nivel de limpieza<\/li>\n<li>Establecimiento de l\u00edmites<\/li>\n<\/ul>\n<p><strong>Lecci\u00f3n 12: <a href=\"https:\/\/gxp-training.com\/online-course\/computer-system-validation-csv\/\">Validaci\u00f3n de sistemas inform\u00e1ticos<\/a><\/strong><\/p>\n<ul>\n<li>Evaluaci\u00f3n de sistemas inform\u00e1ticos para determinar los requisitos de validaci\u00f3n<\/li>\n<li>Hardware<\/li>\n<li>Software<\/li>\n<\/ul>\n<p><strong>Lecci\u00f3n 13: Validaci\u00f3n de m\u00e9todos anal\u00edticos<\/strong><\/p>\n<ul>\n<li>Control de cambios y revalidaci\u00f3n<\/li>\n<li>Revalidaci\u00f3n<\/li>\n<\/ul>\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>En la fabricaci\u00f3n farmac\u00e9utica y de productos sanitarios, la calidad del producto y la seguridad del paciente no son objetivos aspiracionales, sino requisitos regulatorios. Este curso introductorio cubre los principios fundamentales de la cualificaci\u00f3n y la validaci\u00f3n dentro del marco de las Normas de Correcta Fabricaci\u00f3n cGMP vigentes. Una vez completado con \u00e9xito, recibir\u00e1 un [&hellip;]<\/p>\n","protected":false},"featured_media":44163,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[265,271,273],"product_tag":[],"class_list":{"0":"post-57352","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-intersectorial","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>Cualificaci\u00f3n y validaci\u00f3n de procesos: curso certificado online<\/title>\n<meta name=\"description\" content=\"Este curso ense\u00f1a la relevancia de las medidas de cualificaci\u00f3n y validaci\u00f3n para la fabricaci\u00f3n y la investigaci\u00f3n. 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