{"id":57758,"date":"2022-12-06T14:46:47","date_gmt":"2022-12-06T14:46:47","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/integrite-des-donnees-pharmaceutiques-alcoa-et-alcoa\/"},"modified":"2026-06-24T15:54:58","modified_gmt":"2026-06-24T13:54:58","slug":"integrite-des-donnees-pharmaceutiques-alcoa-et-alcoa","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/integrite-des-donnees-pharmaceutiques-alcoa-et-alcoa\/","title":{"rendered":"Int\u00e9grit\u00e9 des donn\u00e9es pharmaceutiques : ALCOA et ALCOA+"},"content":{"rendered":"<p>Les enregistrements incomplets, incoh\u00e9rents ou non tra\u00e7ables figurent parmi les observations les plus fr\u00e9quemment cit\u00e9es lors des inspections pharmaceutiques. Les constats li\u00e9s aux enregistrements incomplets, incoh\u00e9rents ou non tra\u00e7ables figurent parmi les plus fr\u00e9quemment relev\u00e9s lors des inspections pharmaceutiques. Cette formation couvre les principes ALCOA et ALCOA+ que la FDA, l&rsquo;OMS et la MHRA attendent de toute organisation, pour chaque enregistrement, syst\u00e8me et processus, tout au long du cycle de vie du produit. <\/p>\n<p><strong>Ce que vous apprendrez<\/strong><\/p>\n<ul>\n<li>Les principes de l&rsquo;int\u00e9grit\u00e9 des donn\u00e9es et les exigences r\u00e9glementaires (<a href=\"https:\/\/www.fda.gov\/\">FDA<\/a>, <a href=\"https:\/\/www.who.int\/\">OMS<\/a>, MHRA)<\/li>\n<li>L&rsquo;application des principes ALCOA et ALCOA+ pour assurer la conformit\u00e9 des enregistrements<\/li>\n<li>L&rsquo;identification et la pr\u00e9vention des \u00e9carts fr\u00e9quents en mati\u00e8re d&rsquo;int\u00e9grit\u00e9 des donn\u00e9es<\/li>\n<li>La garantie de l&rsquo;int\u00e9grit\u00e9 des donn\u00e9es dans les syst\u00e8mes papier et informatis\u00e9s<\/li>\n<\/ul>\n<p><strong>\u00c0 qui s&rsquo;adresse cette formation ?<\/strong><\/p>\n<ul>\n<li>Les professionnels de l&rsquo;assurance qualit\u00e9 et du contr\u00f4le qualit\u00e9<\/li>\n<li>Le personnel de <a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/bpf-bonnes-pratiques-de-fabrication\/\">fabrication<\/a>, de production et de laboratoire<\/li>\n<li>Les sp\u00e9cialistes des <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/specialiste-des-affaires-reglementaires\/\">affaires r\u00e9glementaires<\/a> et de la conformit\u00e9<\/li>\n<li>Les professionnels responsables de la <a href=\"https:\/\/www.fda.gov\/drugs\/pharmaceutical-quality-resources\/current-good-manufacturing-practice-cgmp-regulations\">documentation BPF<\/a> et de la gestion des donn\u00e9es<\/li>\n<\/ul>\n<p>\u00c0 l&rsquo;issue de la formation, vous recevrez un certificat accr\u00e9dit\u00e9 CPD\/CEU, conforme aux exigences d&rsquo;audit et de documentation r\u00e9glementaire.<\/p>\n<h3>Contenu du cours :<\/h3>\n<p><strong>Introduction<\/strong><\/p>\n<ul>\n<li>Pourquoi l&rsquo;int\u00e9grit\u00e9 des donn\u00e9es est-elle importante dans le secteur pharmaceutique ?<\/li>\n<li>Qui est responsable de garantir l&rsquo;int\u00e9grit\u00e9 des donn\u00e9es ?<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 1 : Aper\u00e7u des lignes directrices sur l&rsquo;int\u00e9grit\u00e9 des donn\u00e9es<\/strong><\/p>\n<p><strong>Le\u00e7on 2 : Principes de l&rsquo;int\u00e9grit\u00e9 des donn\u00e9es<\/strong><\/p>\n<p><strong>Le\u00e7on 3<\/strong> : <strong>Principes ALCOA pour l&rsquo;int\u00e9grit\u00e9 des donn\u00e9es<\/strong><\/p>\n<p><strong>Le\u00e7on 4<\/strong> : <strong>\u00c9carts en mati\u00e8re d&rsquo;int\u00e9grit\u00e9 des donn\u00e9es<\/strong><\/p>\n<ul>\n<li>\u00c9carts fr\u00e9quents<\/li>\n<li>Gestion des \u00e9carts<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 5<\/strong> : <strong>Comment assurer l&rsquo;int\u00e9grit\u00e9 des donn\u00e9es ?<\/strong><\/p>\n<ul>\n<li>Culture qualit\u00e9<\/li>\n<li>Gestion du cycle de vie des donn\u00e9es<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 6<\/strong> : <strong>Int\u00e9grit\u00e9 des donn\u00e9es pour les syst\u00e8mes papier<\/strong><\/p>\n<p><strong>Le\u00e7on 7<\/strong> : <strong>Int\u00e9grit\u00e9 des donn\u00e9es pour les syst\u00e8mes informatis\u00e9s<\/strong><\/p>\n<p><strong>Le\u00e7on 8<\/strong> : <strong>R\u00f4le du syst\u00e8me qualit\u00e9 dans l&rsquo;int\u00e9grit\u00e9 des donn\u00e9es<\/strong><\/p>\n<p><strong>Conclusion<\/strong><\/p>\n<p><strong>Glossaire<\/strong><\/p>\n<p><strong>Quiz<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Les enregistrements incomplets, incoh\u00e9rents ou non tra\u00e7ables figurent parmi les observations les plus fr\u00e9quemment cit\u00e9es lors des inspections pharmaceutiques. Les constats li\u00e9s aux enregistrements incomplets, incoh\u00e9rents ou non tra\u00e7ables figurent parmi les plus fr\u00e9quemment relev\u00e9s lors des inspections pharmaceutiques. Cette formation couvre les principes ALCOA et ALCOA+ que la FDA, l&rsquo;OMS et la MHRA attendent [&hellip;]<\/p>\n","protected":false},"featured_media":59903,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,254,259,263,258,267],"product_tag":[],"class_list":{"0":"post-57758","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-affaires-reglementaires","7":"product_cat-bpf-bonnes-pratiques-de-fabrication","8":"product_cat-laboratoires","9":"product_cat-organisme-de-recherche-sous-contrat-cro","10":"product_cat-pharmaceutique","11":"product_cat-pharmacovigilance-fr","13":"first","14":"instock","15":"taxable","16":"shipping-taxable","17":"purchasable","18":"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 v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Int\u00e9grit\u00e9 des donn\u00e9es pharmaceutiques : Formation en ligne ALCOA \/ ALCOA+<\/title>\n<meta name=\"description\" content=\"Formation certifi\u00e9e en ligne sur l&#039;int\u00e9grit\u00e9 des donn\u00e9es pharmaceutiques. 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