{"id":57958,"date":"2025-06-03T14:58:04","date_gmt":"2025-06-03T12:58:04","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/bpf-pour-lemballage-pharmaceutique-et-iso-15378\/"},"modified":"2025-06-03T14:58:04","modified_gmt":"2025-06-03T12:58:04","slug":"bpf-pour-lemballage-pharmaceutique-et-iso-15378","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/bpf-pour-lemballage-pharmaceutique-et-iso-15378\/","title":{"rendered":"BPF pour l\u2019emballage pharmaceutique et ISO 15378"},"content":{"rendered":"<p>L\u2019ISO 15378 est la norme mondiale pour les mat\u00e9riaux d\u2019emballage primaire utilis\u00e9s dans les produits pharmaceutiques. Elle combine la gestion de la qualit\u00e9 ISO 9001:2015 avec les <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/introduction-aux-bonnes-pratiques-de-fabrication-bpf\/\">Bonnes Pratiques de Fabrication<\/a> (BPF) pour garantir que les composants d\u2019emballage (comme le verre, le caoutchouc, l\u2019aluminium et le plastique) r\u00e9pondent aux normes les plus \u00e9lev\u00e9es de s\u00e9curit\u00e9 et de conformit\u00e9 r\u00e9glementaire. <\/p>\n<p>Pourquoi est-ce important ? Parce que ces mat\u00e9riaux sont en contact direct avec le m\u00e9dicament. Tout d\u00e9faut de qualit\u00e9 peut compromettre l\u2019int\u00e9grit\u00e9 du produit, d\u00e9clencher des rappels ou entra\u00eener des sanctions r\u00e9glementaires. L\u2019<a href=\"https:\/\/www.iso.org\/standard\/70729.html\">ISO 15378<\/a> est d\u00e9sormais une exigence centrale lors des audits de la <a href=\"https:\/\/www.fda.gov\/\">FDA<\/a>, des <a href=\"https:\/\/www.iso.org\/about\/members\">organismes ISO<\/a> et des entreprises pharmaceutiques mondiales.  <\/p>\n<p>Ce cours certifi\u00e9 vous donne les outils pour mettre en \u0153uvre efficacement l\u2019ISO 15378 et les BPF. Votre organisation r\u00e9duira les risques, r\u00e9ussira les audits et prot\u00e9gera la s\u00e9curit\u00e9 des patients. <\/p>\n<div class=\"flex max-w-full flex-col flex-grow\">\n<div class=\"min-h-8 text-message flex w-full flex-col items-end gap-2 whitespace-normal break-words text-start [.text-message+&amp;]:mt-5\" dir=\"auto\" data-message-author-role=\"assistant\" data-message-id=\"32f83479-3523-4e20-9061-a6ccd697f38e\" data-message-model-slug=\"gpt-4o\">\n<div class=\"flex w-full flex-col gap-1 empty:hidden first:pt-[3px]\">\n<div class=\"markdown prose w-full break-words dark:prose-invert light\">\n<p>&nbsp;<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><b>\u00c0 qui s\u2019adresse ce cours ?<\/b><\/p>\n<ul>\n<li>Professionnels de l\u2019emballage et de la production dans les industries pharmaceutiques<\/li>\n<li>Experts en <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/introduction-a-la-qualite-pharmaceutique\/\">Assurance Qualit\u00e9 (AQ)<\/a> et Contr\u00f4le Qualit\u00e9 (CQ)<\/li>\n<li>Sp\u00e9cialistes des <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/specialiste-des-affaires-reglementaires\/\">Affaires R\u00e9glementaires<\/a><\/li>\n<li>Responsables des op\u00e9rations d\u2019emballage<\/li>\n<li>Auditeurs et responsables de la conformit\u00e9<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><b>Ce que vous apprendrez<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\">R\u00f4les critiques des composants d\u2019emballage primaire dans la s\u00e9curit\u00e9 et l\u2019efficacit\u00e9 des m\u00e9dicaments<\/li>\n<li style=\"font-weight: 400;\">Exigences BPF et ISO 15378 \u00e0 travers les r\u00e9glementations mondiales (FDA, UE, OMS)<\/li>\n<li style=\"font-weight: 400;\">Gestion efficace de la conception des emballages et des maquettes<\/li>\n<li style=\"font-weight: 400;\">Bonnes pratiques pour les op\u00e9rations d\u2019emballage afin d\u2019assurer la tra\u00e7abilit\u00e9 et l\u2019efficacit\u00e9<\/li>\n<li style=\"font-weight: 400;\">Comment \u00e9valuer et qualifier les mat\u00e9riaux d\u2019emballage et les fournisseurs<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>Chaque module comprend des \u00e9tudes de cas r\u00e9els, des \u00e9valuations interactives et des outils pour appliquer les connaissances dans votre r\u00f4le quotidien. Une fois la formation r\u00e9ussie, vous recevrez un certificat valid\u00e9, accr\u00e9dit\u00e9 par des cr\u00e9dits CPD\/CEU et reconnu par les auditeurs. <\/p>\n<p>&nbsp;<\/p>\n<h3><b>Programme :<\/b><\/h3>\n<p><b>Vid\u00e9o d\u2019introduction<\/b><\/p>\n<p><b>Le\u00e7on 1 : Composants d\u2019emballage<\/b><\/p>\n<p><b>Le\u00e7on 2 : Exigences r\u00e9glementaires et BPF<\/b><\/p>\n<p><b>Le\u00e7on 3 : Conception d\u2019emballage et gestion des maquettes<\/b><\/p>\n<p><b>Le\u00e7on 4 : Processus et op\u00e9rations d\u2019emballage<\/b><\/p>\n<p><b>Le\u00e7on 5 : Test et \u00e9valuation des mat\u00e9riaux d\u2019emballage<\/b><\/p>\n<p><b>Le\u00e7on 6 : Consid\u00e9rations relatives aux fournisseurs et \u00e0 la qualit\u00e9<\/b><\/p>\n<p><b>Conclusion<\/b><\/p>\n<p><b>\u00c9valuation<\/b><\/p>\n","protected":false},"excerpt":{"rendered":"<p>L\u2019ISO 15378 est la norme mondiale pour les mat\u00e9riaux d\u2019emballage primaire utilis\u00e9s dans les produits pharmaceutiques. Elle combine la gestion de la qualit\u00e9 ISO 9001:2015 avec les Bonnes Pratiques de Fabrication (BPF) pour garantir que les composants d\u2019emballage (comme le verre, le caoutchouc, l\u2019aluminium et le plastique) r\u00e9pondent aux normes les plus \u00e9lev\u00e9es de s\u00e9curit\u00e9 [&hellip;]<\/p>\n","protected":false},"featured_media":48901,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[257,254,258],"product_tag":[],"class_list":{"0":"post-57958","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-assurance-qualite","7":"product_cat-bpf-bonnes-pratiques-de-fabrication","8":"product_cat-pharmaceutique","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>BPF pour l\u2019emballage pharmaceutique ISO 15378<\/title>\n<meta name=\"description\" content=\"Apprenez les BPF pour l\u2019emballage pharmaceutique et les exigences de l\u2019ISO 15378. 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