{"id":57773,"date":"2024-09-23T10:26:01","date_gmt":"2024-09-23T09:26:01","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/21-cfr-partie-58-bpl-pour-les-laboratoires-non-cliniques\/"},"modified":"2024-09-23T10:26:01","modified_gmt":"2024-09-23T08:26:01","slug":"21-cfr-partie-58-bpl-pour-les-laboratoires-non-cliniques","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/21-cfr-partie-58-bpl-pour-les-laboratoires-non-cliniques\/","title":{"rendered":"21 CFR Partie 58 : BPL pour les laboratoires non cliniques"},"content":{"rendered":"<p>Pour les laboratoires non cliniques op\u00e9rant dans la recherche pharmaceutique, biotechnologique ou biom\u00e9dicale, la conformit\u00e9 \u00e0 la <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-references\/nonclinical-laboratories-inspected-under-good-laboratory-practices\">21 CFR Partie 58<\/a> est une exigence r\u00e9glementaire de base. Ce cours offre une introduction approfondie aux exigences des <a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/bpl-bonnes-pratiques-de-laboratoire\/\">Bonnes Pratiques de Laboratoire<\/a> (BPL) d\u00e9finies dans cette r\u00e9glementation, couvrant les r\u00f4les du personnel, les normes d\u2019installations, la manipulation des articles d\u2019essai et les obligations de tenue de registres. <\/p>\n<p><strong>Ce que vous apprendrez ?<\/strong><\/p>\n<ul>\n<li>Historique et importance des BPL dans les laboratoires non cliniques<\/li>\n<li>Exploration d\u00e9taill\u00e9e des r\u00e9glementations BPL de la 21 CFR Partie 58<\/li>\n<li>Comprendre l\u2019organisation et les r\u00f4les du personnel dans la conformit\u00e9 aux BPL<\/li>\n<li>Aper\u00e7u des installations, des \u00e9quipements et des op\u00e9rations impliqu\u00e9s dans les laboratoires non cliniques<\/li>\n<li>Examen approfondi des articles d\u2019essai et de contr\u00f4le et de leur manipulation<\/li>\n<li>Lignes directrices pour la tenue des registres, la r\u00e9daction de rapports et la gestion de la disqualification des installations d\u2019essai<\/li>\n<\/ul>\n<p><strong>Qui devrait s\u2019inscrire ?<\/strong><br \/>\nCe <a href=\"https:\/\/gxp-training.com\/fr\/cours-gxp-2\/\">cours<\/a> est id\u00e9al pour les professionnels impliqu\u00e9s dans les \u00e9tudes de laboratoire non cliniques, y compris les techniciens de laboratoire et le personnel d\u2019assurance qualit\u00e9. Il est \u00e9galement b\u00e9n\u00e9fique pour ceux des secteurs pharmaceutique, biotechnologique et des <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/bpf-pour-les-dispositifs-medicaux-et-fda-21-cfr-part-820\/\">dispositifs m\u00e9dicaux<\/a> qui cherchent \u00e0 s\u2019assurer que leurs op\u00e9rations respectent les normes BPL. <\/p>\n<p>Apr\u00e8s avoir r\u00e9ussi, les participants recevront un <strong>certificat de formation GXP reconnu internationalement, accr\u00e9dit\u00e9 avec des cr\u00e9dits DPC\/UFC<\/strong><\/p>\n<h3><strong>Programme<\/strong><\/h3>\n<p><b>Introduction<\/b><br \/>\n<b>Le\u00e7on 1 : Pourquoi les BPL sont-elles importantes dans les laboratoires non cliniques ?<\/b><br \/>\n<b>Le\u00e7on 2 : Aper\u00e7u de la r\u00e9glementation BPL (21 CFR Partie 58)<\/b><br \/>\n<b>Le\u00e7on 3 : Dispositions g\u00e9n\u00e9rales, organisation et personnel<\/b><br \/>\n<b>Le\u00e7on 4 : Installations<\/b><br \/>\n<b>Le\u00e7on 5 : \u00c9quipements et fonctionnement des installations d\u2019essai<\/b><br \/>\n<b>Le\u00e7on 6 : Articles d\u2019essai et de contr\u00f4le<\/b><br \/>\n<b>Le\u00e7on 7 : Protocole et conduite d\u2019une \u00e9tude de laboratoire non clinique<\/b><br \/>\n<b>Le\u00e7on 8 : Registres et rapports<\/b><br \/>\n<b>Le\u00e7on 9 : Disqualification et installations d\u2019essai<\/b><br \/>\n<b>Conclusion<\/b><br \/>\n<b>\u00c9valuation finale<\/b><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Pour les laboratoires non cliniques op\u00e9rant dans la recherche pharmaceutique, biotechnologique ou biom\u00e9dicale, la conformit\u00e9 \u00e0 la 21 CFR Partie 58 est une exigence r\u00e9glementaire de base. Ce cours offre une introduction approfondie aux exigences des Bonnes Pratiques de Laboratoire (BPL) d\u00e9finies dans cette r\u00e9glementation, couvrant les r\u00f4les du personnel, les normes d\u2019installations, la manipulation [&hellip;]<\/p>\n","protected":false},"featured_media":47611,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[257,277,256,259,263,258],"product_tag":[],"class_list":{"0":"post-57773","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-assurance-qualite","7":"product_cat-bpl-bonnes-pratiques-de-laboratoire","8":"product_cat-dispositifs-medicaux","9":"product_cat-laboratoires","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>21 CFR Partie 58 : BPL pour les laboratoires non cliniques - Formation certifi\u00e9e<\/title>\n<meta name=\"description\" content=\"Ma\u00eetrisez les Bonnes Pratiques de Laboratoire (BPL) avec ce cours certifi\u00e9 21 CFR Partie 58. 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