{"id":57380,"date":"2022-05-23T13:41:51","date_gmt":"2022-05-23T11:41:51","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/inspections-de-conformite-reglementaire-et-audits-externes\/"},"modified":"2022-05-23T13:41:51","modified_gmt":"2022-05-23T11:41:51","slug":"inspections-de-conformite-reglementaire-et-audits-externes","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/inspections-de-conformite-reglementaire-et-audits-externes\/","title":{"rendered":"Inspections de conformit\u00e9 r\u00e9glementaire et audits externes"},"content":{"rendered":"<p>Les inspections r\u00e9glementaires par la <a href=\"https:\/\/www.fda.gov\/\">FDA<\/a> et l\u2019<a href=\"https:\/\/www.who.int\/\">OMS<\/a> sont un test d\u00e9cisif pour toute op\u00e9ration <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/introduction-aux-bonnes-pratiques-de-fabrication-bpf\/\">conforme aux BPF<\/a>. Ce cours offre un aper\u00e7u pratique du fonctionnement des inspections et des audits externes, de ce que les inspecteurs recherchent et de la mani\u00e8re de d\u00e9velopper une pr\u00e9paration durable aux inspections pour l\u2019ensemble de vos syst\u00e8mes qualit\u00e9. <\/p>\n<p>D\u00e9velopp\u00e9 par des experts en affaires r\u00e9glementaires form\u00e9s \u00e0 la Northeastern University et guid\u00e9 par un sp\u00e9cialiste senior de l\u2019industrie, le cours offre un aper\u00e7u clair et pratique de la pr\u00e9paration aux inspections.<\/p>\n<p>Apr\u00e8s avoir r\u00e9ussi le cours, vous recevrez un <strong>certificat valid\u00e9 et accr\u00e9dit\u00e9 avec des cr\u00e9dits CPD\/CEU<\/strong>, adapt\u00e9 \u00e0 la documentation d\u2019audit et de conformit\u00e9.<\/p>\n<p><strong>Qui devrait s\u2019inscrire ?<\/strong><\/p>\n<ul>\n<li>Professionnels de l\u2019<a href=\"https:\/\/gxp-training.com\/fr\/online-course\/gestion-des-risques-qualite\/\">Assurance Qualit\u00e9<\/a> et du Contr\u00f4le Qualit\u00e9<\/li>\n<li>Sp\u00e9cialistes des <a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/affaires-reglementaires\/\">Affaires R\u00e9glementaires<\/a> et de la conformit\u00e9<\/li>\n<li>\u00c9quipes de fabrication et d\u2019op\u00e9rations<\/li>\n<li>Personnel de pr\u00e9paration aux audits et inspections <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/introduction-aux-bonnes-pratiques-de-fabrication-bpf\/\">BPF<\/a><\/li>\n<\/ul>\n<p><strong>Ce que vous apprendrez<\/strong><\/p>\n<ul>\n<li>Comprendre l\u2019objectif des inspections r\u00e9glementaires et des audits externes dans les environnements BPF<\/li>\n<li>Identifier les agences responsables du suivi de la conformit\u00e9 (FDA, OMS)<\/li>\n<li>Reconna\u00eetre les diff\u00e9rents types d\u2019inspections et ce que chacune \u00e9value<\/li>\n<li>Se pr\u00e9parer aux attentes d\u2019inspection de la FDA pour les syst\u00e8mes qualit\u00e9 cl\u00e9s<\/li>\n<li>Renforcer la pr\u00e9paration aux inspections et soutenir la conformit\u00e9 continue aux BPF<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3>Programme<\/h3>\n<p><strong>Introduction<\/strong><\/p>\n<p><strong>Le\u00e7on 1 : Pourquoi les inspections de conformit\u00e9 r\u00e9glementaire et les audits externes sont-ils importants ?<\/strong><\/p>\n<p><strong>Le\u00e7on 2 : Les directives <a href=\"https:\/\/www.fda.gov\/media\/71553\/download\">ICH Q10<\/a> sur les inspections r\u00e9glementaires<\/strong><\/p>\n<ul>\n<li>Atteindre la r\u00e9alisation des produits<\/li>\n<li>\u00c9tablir et maintenir un \u00e9tat de contr\u00f4le<\/li>\n<li>Faciliter l\u2019am\u00e9lioration continue<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 3 : Quelles entreprises sont soumises aux inspections de conformit\u00e9 et aux audits externes ?<\/strong><\/p>\n<p><strong>Le\u00e7on 4 : Qui surveille et audite la conformit\u00e9 aux BPF ?<\/strong><\/p>\n<ul>\n<li>Agences r\u00e9glementaires responsables des audits BPF<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 5 : Types d\u2019inspections de conformit\u00e9 r\u00e9glementaire<\/strong><\/p>\n<ul>\n<li>Inspection de routine<\/li>\n<li>Inspection concise<\/li>\n<li>Inspection de suivi<\/li>\n<li>Inspection sp\u00e9ciale<\/li>\n<li>Examen des syst\u00e8mes qualit\u00e9<\/li>\n<li>Fr\u00e9quence des inspections<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 6 : Directives de la FDA pour la strat\u00e9gie d\u2019inspection et d\u2019audit de conformit\u00e9<\/strong><\/p>\n<ul>\n<li>Syst\u00e8me qualit\u00e9<\/li>\n<li>Inspection du syst\u00e8me qualit\u00e9 (Phase 1 et Phase 2)<\/li>\n<li>Examens des produits<\/li>\n<li>Examens des plaintes<\/li>\n<li>Investigations sur les \u00e9carts et les d\u00e9faillances (pour la fabrication et les tests)<\/li>\n<li>Contr\u00f4le des changements<\/li>\n<li>Projets d\u2019am\u00e9lioration des produits<\/li>\n<\/ul>\n<p><strong>Glossaire<\/strong><\/p>\n<p><strong>Quiz<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Les inspections r\u00e9glementaires par la FDA et l\u2019OMS sont un test d\u00e9cisif pour toute op\u00e9ration conforme aux BPF. Ce cours offre un aper\u00e7u pratique du fonctionnement des inspections et des audits externes, de ce que les inspecteurs recherchent et de la mani\u00e8re de d\u00e9velopper une pr\u00e9paration durable aux inspections pour l\u2019ensemble de vos syst\u00e8mes qualit\u00e9. [&hellip;]<\/p>\n","protected":false},"featured_media":44364,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,274,254,256,263,258],"product_tag":[],"class_list":{"0":"post-57380","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-affaires-reglementaires","7":"product_cat-bpc-essais-cliniques","8":"product_cat-bpf-bonnes-pratiques-de-fabrication","9":"product_cat-dispositifs-medicaux","10":"product_cat-organisme-de-recherche-sous-contrat-cro","11":"product_cat-pharmaceutique","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>Inspections r\u00e9glementaires et audits externes \u2013 Cours certifi\u00e9<\/title>\n<meta name=\"description\" content=\"Ma\u00eetrisez les inspections r\u00e9glementaires et les audits externes selon les directives BPF de la FDA et de l\u2019OMS. 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