{"id":57666,"date":"2023-05-05T09:40:09","date_gmt":"2023-05-05T08:40:09","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/validation-des-systemes-informatises-csv-et-gamp-5\/"},"modified":"2023-05-05T09:40:09","modified_gmt":"2023-05-05T07:40:09","slug":"validation-des-systemes-informatises-csv-et-gamp-5","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/validation-des-systemes-informatises-csv-et-gamp-5\/","title":{"rendered":"Validation des Syst\u00e8mes Informatis\u00e9s (CSV) et GAMP 5"},"content":{"rendered":"<p>Dans les environnements pharmaceutiques r\u00e9glement\u00e9s, un syst\u00e8me informatis\u00e9 non valid\u00e9 constitue un risque de non-conformit\u00e9. La <a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC11416705\/\">Validation des Syst\u00e8mes Informatis\u00e9s<\/a> (CSV) est le processus structur\u00e9 qui d\u00e9montre que les syst\u00e8mes fonctionnent de mani\u00e8re fiable, prot\u00e8gent l&rsquo;int\u00e9grit\u00e9 des donn\u00e9es et satisfont aux r\u00e9glementations, notamment le <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/introduction-a-la-formation-en-ligne-fda-21-cfr-part-11\/\">FDA 21 CFR Part 11<\/a> et l&rsquo;<a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2016-11\/annex11_01-2011_en_0.pdf\">Annexe 11 de l&rsquo;UE<\/a>. Cette formation pr\u00e9sente le cycle de vie de la CSV et l&rsquo;approche bas\u00e9e sur les risques de GAMP 5 pour la classification des syst\u00e8mes et la planification de la validation. <\/p>\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<p>&nbsp;<\/p>\n<p><strong>\u00c0 qui s&rsquo;adresse cette formation ?<\/strong><\/p>\n<ul>\n<li>Professionnels de l&rsquo;<a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/assurance-qualite\/\">assurance qualit\u00e9<\/a> et de la validation<\/li>\n<li>Sp\u00e9cialistes informatiques et syst\u00e8mes dans les entreprises <a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/pharmaceutique\/\">pharmaceutiques<\/a> et biotechnologiques<\/li>\n<li>Personnel des affaires r\u00e9glementaires supervisant les syst\u00e8mes informatis\u00e9s<\/li>\n<li>Chefs de projet impliqu\u00e9s dans la mise en \u0153uvre et la validation de syst\u00e8mes<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong style=\"font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', Arial, 'Noto Sans', sans-serif, 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Noto Color Emoji'\">Que allez-vous apprendre ?<\/strong><\/p>\n<ul>\n<li>Importance et r\u00f4le de la CSV dans les industries r\u00e9glement\u00e9es<\/li>\n<li>Phases cl\u00e9s du cycle de vie de la CSV : concept, projet, exploitation, retrait<\/li>\n<li>Bonnes pratiques pour la planification de la validation, la documentation et l&rsquo;assurance qualit\u00e9<\/li>\n<li>Classification des composants logiciels et mat\u00e9riels selon les directives GAMP\u00ae5<\/li>\n<li>\u00c9laboration et utilisation de documents de validation essentiels tels que le CDS et les plans de validation<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3>Programme :<\/h3>\n<p><strong>Introduction<\/strong><br \/>\n<strong>Le\u00e7on 1 : Introduction aux directives GAMP 5 pour la CSV<\/strong><br \/>\n<strong>Le\u00e7on 2 : Processus de validation en CSV<\/strong><br \/>\n<strong>Le\u00e7on 3 : Phase 1 de la CSV &#8211; Phase de concept<\/strong><br \/>\n<strong>Le\u00e7on 4 : Phase 2 de la CSV &#8211; Phase de projet<\/strong><br \/>\n<strong>Le\u00e7on 5 : Phase 3 de la CSV &#8211; Phase d&rsquo;exploitation<\/strong><br \/>\n<strong>Le\u00e7on 6 : Phase 4 de la CSV &#8211; Phase de retrait<\/strong><br \/>\n<strong>Le\u00e7on 7 : Multi-phases et liste de contr\u00f4le pour la CSV<\/strong><br \/>\n<strong>Glossaire<\/strong><br \/>\n<strong>\u00c9valuation<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Dans les environnements pharmaceutiques r\u00e9glement\u00e9s, un syst\u00e8me informatis\u00e9 non valid\u00e9 constitue un risque de non-conformit\u00e9. La Validation des Syst\u00e8mes Informatis\u00e9s (CSV) est le processus structur\u00e9 qui d\u00e9montre que les syst\u00e8mes fonctionnent de mani\u00e8re fiable, prot\u00e8gent l&rsquo;int\u00e9grit\u00e9 des donn\u00e9es et satisfont aux r\u00e9glementations, notamment le FDA 21 CFR Part 11 et l&rsquo;Annexe 11 de l&rsquo;UE. Cette [&hellip;]<\/p>\n","protected":false},"featured_media":43909,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[257,274,254,277,256,259,263,258,264],"product_tag":[],"class_list":{"0":"post-57666","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-assurance-qualite","7":"product_cat-bpc-essais-cliniques","8":"product_cat-bpf-bonnes-pratiques-de-fabrication","9":"product_cat-bpl-bonnes-pratiques-de-laboratoire","10":"product_cat-dispositifs-medicaux","11":"product_cat-laboratoires","12":"product_cat-organisme-de-recherche-sous-contrat-cro","13":"product_cat-pharmaceutique","14":"product_cat-transversal","16":"first","17":"instock","18":"taxable","19":"shipping-taxable","20":"purchasable","21":"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 et certification en Validation des Syst\u00e8mes Informatis\u00e9s (CSV)<\/title>\n<meta name=\"description\" content=\"Apprenez la CSV et GAMP 5 dans cette formation certifi\u00e9e en ligne pour les sciences de la vie. Acqu\u00e9rez des comp\u00e9tences pratiques, une certification CPD\/CEU et faites progresser votre carri\u00e8re dans la conformit\u00e9 pharmaceutique.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/gxp-training.com\/fr\/online-course\/validation-des-systemes-informatises-csv-et-gamp-5\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Formation en ligne et certification en Validation des Syst\u00e8mes Informatis\u00e9s (CSV)\" \/>\n<meta property=\"og:description\" content=\"Apprenez la CSV et GAMP 5 dans cette formation certifi\u00e9e en ligne pour les sciences de la vie. 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