{"id":57153,"date":"2022-05-27T12:10:19","date_gmt":"2022-05-27T10:10:19","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/introduccion-a-las-buenas-practicas-de-fabricacion-en-la-ue\/"},"modified":"2022-05-27T12:10:19","modified_gmt":"2022-05-27T10:10:19","slug":"introduccion-a-las-buenas-practicas-de-fabricacion-en-la-ue","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/es\/online-course\/introduccion-a-las-buenas-practicas-de-fabricacion-en-la-ue\/","title":{"rendered":"Introducci\u00f3n a las Buenas Pr\u00e1cticas de Fabricaci\u00f3n en la UE"},"content":{"rendered":"<p>Partiendo de los fundamentos de la industria farmac\u00e9utica, que tiene una poderosa representaci\u00f3n en Europa, este curso destaca la importancia de las Buenas Pr\u00e1cticas de Fabricaci\u00f3n (BPF) para garantizar que los productos alimentarios, sanitarios y cosm\u00e9ticos sean seguros y eficaces para su uso. La evoluci\u00f3n del concepto para incluir las Buenas Pr\u00e1cticas de Fabricaci\u00f3n Actuales (CGMP) y las Buenas Pr\u00e1cticas de Fabricaci\u00f3n Automatizada (GAMP), que emplean procedimientos actualizados y tecnolog\u00eda automatizada respectivamente, se\u00f1ala la naturaleza progresiva de la industria farmac\u00e9utica y sus agencias reguladoras en la Uni\u00f3n Europea (UE). <\/p>\n<p>&nbsp;<\/p>\n<p>En este curso, ofrecemos una s\u00edntesis sobre el tema a trav\u00e9s de una experiencia online interactiva. Este material ha sido elaborado por un equipo de Expertos en Asuntos Regulatorios con Cualificaci\u00f3n de Northeastern University, Boston, dirigido por un Miembro Senior capaz de articular teor\u00eda y pr\u00e1ctica. <\/p>\n<p>&nbsp;<\/p>\n<h3>Programa<\/h3>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 1: Introducci\u00f3n a la Industria Farmac\u00e9utica<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>EFPIA \u2013 La Organizaci\u00f3n Matriz de la Industria<\/li>\n<li>Peque\u00f1a, Pero Gigante<\/li>\n<li>Europa como Centro de I+D<\/li>\n<li>La Importancia de la I+D en el Sector Farmac\u00e9utico<\/li>\n<li>Comercio de Productos Farmac\u00e9uticos en la UE y la Cadena de Valor Global<\/li>\n<li>An\u00e1lisis de los Principales Problemas Comerciales para la Industria Farmac\u00e9utica Europea<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 2: Introducci\u00f3n a las Buenas Pr\u00e1cticas de Fabricaci\u00f3n (BPF)<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Los 5 Componentes de las BPF<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 3: \u00bfCu\u00e1l es la Diferencia entre BPF y CGMP?<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 4: Normativa en la UE<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>El papel de la EMA<\/li>\n<li>Autoridades Nacionales Competentes<\/li>\n<li>Autorizaci\u00f3n y Supervisi\u00f3n de Fabricantes<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 5: Monitorizaci\u00f3n de la Seguridad de los Medicamentos<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Ensayos cl\u00ednicos<\/li>\n<li>Cooperaci\u00f3n Internacional<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 6: \u00bfQu\u00e9 son las Normas BPF?<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>\u00bfQu\u00e9 es GAMP?<\/li>\n<li>\u00bfQu\u00e9 es la Validaci\u00f3n de Sistemas Informatizados?<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 7: Normativa y Directrices de las BPF de la UE<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 8: Cumplimiento de las BPF en la UE<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Vacunas COVID-19: Desarrollo, evaluaci\u00f3n, aprobaci\u00f3n y monitorizaci\u00f3n en la UE<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 9: Marco Regulatorio S\u00f3lido y Experiencia Cient\u00edfica en la UE<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Evaluaci\u00f3n Cient\u00edfica y Procesos de Aprobaci\u00f3n<\/li>\n<li>Evaluaci\u00f3n Acelerada<\/li>\n<li>Monitorizaci\u00f3n Est\u00e1ndar<\/li>\n<li>Monitorizaci\u00f3n a Gran Escala en el Contexto de la Pandemia<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Conclusi\u00f3n<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Examen Final<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Certificaci\u00f3n<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Partiendo de los fundamentos de la industria farmac\u00e9utica, que tiene una poderosa representaci\u00f3n en Europa, este curso destaca la importancia de las Buenas Pr\u00e1cticas de Fabricaci\u00f3n (BPF) para garantizar que los productos alimentarios, sanitarios y cosm\u00e9ticos sean seguros y eficaces para su uso. La evoluci\u00f3n del concepto para incluir las Buenas Pr\u00e1cticas de Fabricaci\u00f3n Actuales [&hellip;]<\/p>\n","protected":false},"featured_media":43192,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[276,265,271,269],"product_tag":[],"class_list":{"0":"post-57153","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-garantia-de-calidad","9":"product_cat-productos-farmaceuticos","11":"first","12":"instock","13":"taxable","14":"shipping-taxable","15":"purchasable","16":"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>Buenas Pr\u00e1cticas de Fabricaci\u00f3n (BPF) en la UE: Curso Certificado Online<\/title>\n<meta name=\"description\" content=\"\u00bfDesea aprender sobre el cumplimiento de las Buenas Pr\u00e1cticas de Fabricaci\u00f3n (BPF) en la UE? Obtenga su certificaci\u00f3n BPF ahora gracias a nuestro curso online con los mejores expertos. Acreditado CPD \/ CEU.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/gxp-training.com\/es\/online-course\/introduccion-a-las-buenas-practicas-de-fabricacion-en-la-ue\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Buenas Pr\u00e1cticas de Fabricaci\u00f3n (BPF) en la UE: Curso Certificado Online\" \/>\n<meta property=\"og:description\" content=\"\u00bfDesea aprender sobre el cumplimiento de las Buenas Pr\u00e1cticas de Fabricaci\u00f3n (BPF) en la UE? Obtenga su certificaci\u00f3n BPF ahora gracias a nuestro curso online con los mejores expertos. 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