{"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":"2022-12-06T14:46:47","modified_gmt":"2022-12-06T13:46:47","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. Cette formation aborde la source de ce risque en couvrant les principes ALCOA et ALCOA+ que la FDA, l&rsquo;OMS et la MHRA attendent des organisations pour chaque enregistrement, syst\u00e8me et processus tout au long du cycle de vie du produit. <\/p>\n<p><strong>Que allez-vous apprendre ?<\/strong><\/p>\n<ul>\n<li>Principes de l&rsquo;int\u00e9grit\u00e9 des donn\u00e9es et exigences r\u00e9glementaires (<a href=\"https:\/\/www.fda.gov\/\">FDA<\/a>, <a href=\"https:\/\/www.who.int\/\">OMS<\/a>, MHRA)<\/li>\n<li>Appliquer les principes ALCOA et ALCOA+ pour garantir des enregistrements conformes<\/li>\n<li>Identifier et pr\u00e9venir les violations courantes de l&rsquo;int\u00e9grit\u00e9 des donn\u00e9es<\/li>\n<li>Assurer 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>Professionnels de l&rsquo;assurance qualit\u00e9 et du contr\u00f4le qualit\u00e9<\/li>\n<li>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>Sp\u00e9cialistes des <a href=\"https:\/\/gxp-training.com\/online-course\/regulatory-affairs-specialist-training-certification\/\">affaires r\u00e9glementaires<\/a> et de la conformit\u00e9<\/li>\n<li>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 <strong>certificat valid\u00e9 accr\u00e9dit\u00e9 avec des cr\u00e9dits CPD\/CEU<\/strong>, adapt\u00e9 \u00e0 la documentation d&rsquo;audit et de conformit\u00e9.<\/p>\n<h3>Programme :<\/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>Violations de l&rsquo;int\u00e9grit\u00e9 des donn\u00e9es<\/strong><\/p>\n<ul>\n<li>Probl\u00e8mes courants<\/li>\n<li>Traitement des violations<\/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. Cette formation aborde la source de ce risque en couvrant les principes ALCOA et ALCOA+ que la FDA, l&rsquo;OMS et la MHRA attendent des organisations pour chaque enregistrement, syst\u00e8me et processus tout au long du cycle [&hellip;]<\/p>\n","protected":false},"featured_media":43199,"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","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 v27.5 - 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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