{"id":57738,"date":"2022-12-09T15:42:12","date_gmt":"2022-12-09T15:42:12","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/bonnes-pratiques-de-documentation-bpd\/"},"modified":"2022-12-09T15:42:12","modified_gmt":"2022-12-09T14:42:12","slug":"bonnes-pratiques-de-documentation-bpd","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/bonnes-pratiques-de-documentation-bpd\/","title":{"rendered":"Bonnes pratiques de documentation (BPD)"},"content":{"rendered":"<p>Les erreurs de documentation figurent parmi les constatations les plus courantes lors des inspections <a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/bpf-bonnes-pratiques-de-fabrication\/\">BPF<\/a>, et parmi les plus \u00e9vitables. Ce cours couvre les <a href=\"https:\/\/www.fda.gov\/media\/185615\/download\">bonnes pratiques de documentation<\/a> (BPD) sur lesquelles s\u2019appuient les organisations r\u00e9glement\u00e9es pour garantir que les dossiers sont pr\u00e9cis, conformes et pr\u00eats pour l\u2019audit dans l\u2019ensemble des op\u00e9rations de fabrication, d\u2019essai et de qualit\u00e9. <\/p>\n<p><strong>Qu\u2019allez-vous apprendre ?<\/strong><\/p>\n<ul>\n<li>Principes des <a href=\"https:\/\/www.fda.gov\/media\/185615\/download\">bonnes pratiques de documentation<\/a> en BPF<\/li>\n<li>Comment remplir, r\u00e9viser et conserver les diff\u00e9rents documents BPF<\/li>\n<li>Identifier et corriger les erreurs de documentation courantes<\/li>\n<li>Assurer la conformit\u00e9 gr\u00e2ce \u00e0 un contr\u00f4le et une conservation appropri\u00e9s des documents<\/li>\n<\/ul>\n<p><strong>\u00c0 qui s\u2019adresse cette formation ?<\/strong><\/p>\n<ul>\n<li>Professionnels de l\u2019assurance et du contr\u00f4le qualit\u00e9<\/li>\n<li><a href=\"https:\/\/gxp-training.com\/online-course\/regulatory-affairs-specialist-training-certification\/\">Sp\u00e9cialistes des affaires r\u00e9glementaires<\/a><\/li>\n<li>Personnel de fabrication et de laboratoire g\u00e9rant la documentation<\/li>\n<li><a href=\"https:\/\/gxp-training.com\/fr\/online-course\/audit-bpf-interne-role-de-lauditeur-bpf\/\">Auditeurs internes<\/a> et \u00e9quipes de conformit\u00e9<\/li>\n<\/ul>\n<p>Une fois la formation r\u00e9ussie, vous recevrez un <strong>certificat valid\u00e9 accr\u00e9dit\u00e9 par des cr\u00e9dits CPD\/CEU<\/strong>, adapt\u00e9 \u00e0 la documentation d\u2019audit et de conformit\u00e9.<\/p>\n<h3>Programme :<\/h3>\n<p><strong>Introduction<\/strong><\/p>\n<p><strong>Chapitre 1 : Que sont les bonnes pratiques de documentation ?<\/strong><\/p>\n<p><strong>Chapitre 2 : Comment et quand appliquer les bonnes pratiques de documentation<\/strong><\/p>\n<p><strong>Chapitre 3 : Types de documents<\/strong><\/p>\n<ul dir=\"ltr\">\n<li>Documents d\u2019engagement (ex. : demandes d\u2019AMM, dossiers permanents de la substance active)<\/li>\n<li>Documents directifs (ex. : sp\u00e9cifications, proc\u00e9dures d\u2019essai types, SOP, dossiers de fabrication ma\u00eetres)<\/li>\n<li>Documents d\u2019enregistrement (ex. : protocoles, dossiers de lot, registres, rapports d\u2019\u00e9talonnage)<\/li>\n<\/ul>\n<p><strong>Chapitre 4 : Normes de bonne documentation<\/strong><\/p>\n<ul dir=\"ltr\">\n<li>Approbation<\/li>\n<li>Clart\u00e9<\/li>\n<li>R\u00e9vision p\u00e9riodique et mise \u00e0 jour<\/li>\n<li>Pr\u00e9sentation formelle<\/li>\n<li>Enregistrements<\/li>\n<\/ul>\n<p><strong>Chapitre 5 : Comment remplir la documentation, y compris les formulaires de collecte de donn\u00e9es et les dossiers de lot<\/strong><\/p>\n<p><strong>Chapitre 6 : Comment ajouter des donn\u00e9es brutes aux formulaires et aux cahiers de laboratoire<\/strong><\/p>\n<p><strong>Chapitre 7 : Erreurs types<\/strong><\/p>\n<p><strong>Chapitre 8 : Comment corriger les erreurs de saisie et les omissions<\/strong><\/p>\n<p><strong>Chapitre 9 : Comment dater, signer et marquer les enregistrements<\/strong><\/p>\n<p><strong>\u00c9valuation<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Les erreurs de documentation figurent parmi les constatations les plus courantes lors des inspections BPF, et parmi les plus \u00e9vitables. Ce cours couvre les bonnes pratiques de documentation (BPD) sur lesquelles s\u2019appuient les organisations r\u00e9glement\u00e9es pour garantir que les dossiers sont pr\u00e9cis, conformes et pr\u00eats pour l\u2019audit dans l\u2019ensemble des op\u00e9rations de fabrication, d\u2019essai et [&hellip;]<\/p>\n","protected":false},"featured_media":55217,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[257,274,281,254,277,256,259,263,258,264],"product_tag":[],"class_list":{"0":"post-57738","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-bpd-bonnes-pratiques-de-distribution","9":"product_cat-bpf-bonnes-pratiques-de-fabrication","10":"product_cat-bpl-bonnes-pratiques-de-laboratoire","11":"product_cat-dispositifs-medicaux","12":"product_cat-laboratoires","13":"product_cat-organisme-de-recherche-sous-contrat-cro","14":"product_cat-pharmaceutique","15":"product_cat-transversal","17":"first","18":"instock","19":"taxable","20":"shipping-taxable","21":"purchasable","22":"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>Bonnes pratiques de documentation (BPD) : formation certifiante en ligne<\/title>\n<meta name=\"description\" content=\"Bonnes pratiques de documentation (BPD). Commencez votre formation certifiante en ligne avec les meilleurs experts BPF. Obtenez votre certification. Accr\u00e9dit\u00e9 CPD et CEU.\" \/>\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\/bonnes-pratiques-de-documentation-bpd\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bonnes pratiques de documentation (BPD) : formation certifiante en ligne\" \/>\n<meta property=\"og:description\" content=\"Bonnes pratiques de documentation (BPD). Commencez votre formation certifiante en ligne avec les meilleurs experts BPF. Obtenez votre certification. 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