{"id":58134,"date":"2025-10-15T18:13:41","date_gmt":"2025-10-15T16:13:41","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/conformite-pic-s-un-guide-complet-pour-les-professionnels-pharmaceutiques-et-hospitaliers\/"},"modified":"2025-10-15T18:13:41","modified_gmt":"2025-10-15T16:13:41","slug":"conformite-pic-s-un-guide-complet-pour-les-professionnels-pharmaceutiques-et-hospitaliers","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/conformite-pic-s-un-guide-complet-pour-les-professionnels-pharmaceutiques-et-hospitaliers\/","title":{"rendered":"Conformit\u00e9 PIC\/S : Un guide complet pour les professionnels pharmaceutiques et hospitaliers"},"content":{"rendered":"<p>Comprendre et se conformer aux normes pharmaceutiques mondiales est essentiel pour garantir la s\u00e9curit\u00e9 des patients et la qualit\u00e9 des produits. Ce cours est con\u00e7u pour aider les professionnels de la sant\u00e9 et de l&rsquo;industrie pharmaceutique \u00e0 naviguer dans les exigences complexes du <a href=\"https:\/\/picscheme.org\/en\/picscheme\">Pharmaceutical Inspection Co-operation Scheme<\/a> (PIC\/S). \u00c0 travers des \u00e9tudes de cas, des strat\u00e9gies de mise en \u0153uvre et des le\u00e7ons interactives, vous apprendrez \u00e0 appliquer les normes PIC\/S dans les milieux industriels et hospitaliers.  <\/p>\n<p><strong>Qui devrait s\u2019inscrire ?<\/strong><br \/>\nCe cours est id\u00e9al pour les professionnels responsables de la conformit\u00e9, de la qualit\u00e9 et des normes op\u00e9rationnelles dans les milieux de la sant\u00e9 et de l&rsquo;industrie pharmaceutique, y compris :<\/p>\n<ul>\n<li>Administrateurs hospitaliers et pharmaciens cliniciens<\/li>\n<li>Directeurs de production et d\u2019op\u00e9rations<\/li>\n<li>Responsables de l\u2019assurance qualit\u00e9 et du contr\u00f4le qualit\u00e9<\/li>\n<li>Sp\u00e9cialistes des affaires r\u00e9glementaires<\/li>\n<li>Directeurs de pharmacie et de laboratoire<\/li>\n<\/ul>\n<p><strong>Ce que vous apprendrez<\/strong><br \/>\n\u00c0 la fin du cours, les apprenants seront capables de :<\/p>\n<ul>\n<li>Comprendre les origines, le cadre et les documents cl\u00e9s du PIC\/S<\/li>\n<li>Appliquer les principes fondamentaux des BPF <a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/bpf-bonnes-pratiques-de-fabrication\/\">PIC\/S<\/a> dans les environnements de fabrication et hospitaliers<\/li>\n<li>Pr\u00e9parer les installations, le personnel et la documentation pour les inspections<\/li>\n<li>Mettre en \u0153uvre des approches bas\u00e9es sur les risques \u00e0 l\u2019aide d\u2019outils de gestion des risques qualit\u00e9 (GRQ) tels que l\u2019AMDE et les diagrammes d\u2019Ishikawa<\/li>\n<li>Assurer l\u2019int\u00e9grit\u00e9 des donn\u00e9es et g\u00e9rer la conformit\u00e9 num\u00e9rique conform\u00e9ment aux principes ALCOA+<\/li>\n<li>Int\u00e9grer les pratiques BPF dans les op\u00e9rations de pharmacie hospitali\u00e8re st\u00e9rile et non st\u00e9rile<\/li>\n<li>Apprendre des \u00e9tudes de cas r\u00e9elles pour am\u00e9liorer la conformit\u00e9 et la performance op\u00e9rationnelle<\/li>\n<\/ul>\n<p>En suivant ce cours, vous serez pr\u00e9par\u00e9 \u00e0 mettre en \u0153uvre les lignes directrices PIC\/S en toute confiance, \u00e0 am\u00e9liorer la conformit\u00e9 au sein de votre organisation et \u00e0 garantir les normes les plus \u00e9lev\u00e9es de qualit\u00e9 et de s\u00e9curit\u00e9 des patients dans les milieux pharmaceutiques et hospitaliers.<\/p>\n<h3>Programme :<\/h3>\n<p><strong>Module 1 : Comprendre le PIC\/S \u2013 Origines et cadre<\/strong><\/p>\n<ul>\n<li>Contexte historique et gen\u00e8se du PIC\/S<\/li>\n<li>Mission, objectifs, structure et adh\u00e9sion<\/li>\n<li>Documents cl\u00e9s et outils d\u2019harmonisation<\/li>\n<li>Avantages de la participation au PIC\/S pour les autorit\u00e9s et l\u2019industrie<\/li>\n<li>\u00c9tude de cas : La trag\u00e9die de la thalidomide et l\u2019\u00e9volution r\u00e9glementaire<\/li>\n<\/ul>\n<p><strong>Module 2 : Lignes directrices fondamentales du PIC\/S <\/strong><\/p>\n<ul>\n<li>Aper\u00e7u du Guide BPF PIC\/S (PE009)<\/li>\n<li>Principes et normes cl\u00e9s des BPF<\/li>\n<\/ul>\n<p><strong>Module 3 : Principes BPF et pr\u00e9paration \u00e0 l\u2019inspection<\/strong><\/p>\n<ul>\n<li>Qualification des installations et des \u00e9quipements<\/li>\n<li>Contr\u00f4les de production et validation des processus<\/li>\n<li>Gestion de la documentation et des enregistrements<\/li>\n<li>Comp\u00e9tence et hygi\u00e8ne du personnel<\/li>\n<li>Contr\u00f4le qualit\u00e9, lib\u00e9ration des lots et gestion des d\u00e9viations<\/li>\n<li>Qualification des fournisseurs et gestion des mat\u00e9riaux<\/li>\n<li>Pr\u00e9paration \u00e0 l\u2019inspection et am\u00e9lioration continue<\/li>\n<\/ul>\n<p><strong>Module 4 : Application des BPF PIC\/S dans les milieux hospitaliers et de la sant\u00e9<\/strong><\/p>\n<ul>\n<li>Port\u00e9e des BPF dans les milieux hospitaliers et de la sant\u00e9<\/li>\n<li>Pr\u00e9paration st\u00e9rile et non st\u00e9rile, reconditionnement<\/li>\n<li>Gestion des salles blanches et des \u00e9quipements<\/li>\n<li>Documentation, dossiers de lots et int\u00e9gration avec les syst\u00e8mes qualit\u00e9 hospitaliers<\/li>\n<li>D\u00e9fis et opportunit\u00e9s dans la mise en \u0153uvre des BPF hospitali\u00e8res<\/li>\n<\/ul>\n<p><strong>Module 5 : Gestion des risques qualit\u00e9<\/strong><\/p>\n<ul>\n<li>Principes de l\u2019ICH Q9 et alignement PIC\/S<\/li>\n<li>AMDE et diagrammes d\u2019Ishikawa (ar\u00eate de poisson)<\/li>\n<li>Prise de d\u00e9cision bas\u00e9e sur les risques dans les d\u00e9viations, le nettoyage et la qualification des \u00e9quipements<\/li>\n<li>Examen continu et int\u00e9gration de la GRQ<\/li>\n<\/ul>\n<p><strong>Module 6 : Int\u00e9grit\u00e9 des donn\u00e9es et conformit\u00e9 num\u00e9rique <\/strong><\/p>\n<ul>\n<li>Fondements de l\u2019int\u00e9grit\u00e9 des donn\u00e9es (ALCOA et ALCOA+)<\/li>\n<li>Tenue de registres \u00e9lectroniques et pistes d\u2019audit<\/li>\n<li>Pr\u00e9vention de la manipulation des donn\u00e9es<\/li>\n<li>Gestion des syst\u00e8mes de donn\u00e9es hybrides et gouvernance<\/li>\n<li>Inspections et audits pour l\u2019int\u00e9grit\u00e9 des donn\u00e9es<\/li>\n<\/ul>\n<p><strong>Module 7 : \u00c9tudes de cas<\/strong><\/p>\n<p><strong>R\u00e9f\u00e9rences<\/strong><\/p>\n<p><strong>Quiz<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Comprendre et se conformer aux normes pharmaceutiques mondiales est essentiel pour garantir la s\u00e9curit\u00e9 des patients et la qualit\u00e9 des produits. Ce cours est con\u00e7u pour aider les professionnels de la sant\u00e9 et de l&rsquo;industrie pharmaceutique \u00e0 naviguer dans les exigences complexes du Pharmaceutical Inspection Co-operation Scheme (PIC\/S). \u00c0 travers des \u00e9tudes de cas, des [&hellip;]<\/p>\n","protected":false},"featured_media":52850,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[258,267],"product_tag":[],"class_list":{"0":"post-58134","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-pharmaceutique","7":"product_cat-pharmacovigilance","9":"first","10":"instock","11":"taxable","12":"shipping-taxable","13":"purchasable","14":"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>Formation en ligne sur la conformit\u00e9 PIC\/S avec certification<\/title>\n<meta name=\"description\" content=\"Apprenez les normes PIC\/S avec notre cours destin\u00e9 aux professionnels pharmaceutiques et hospitaliers. 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