{"id":57160,"date":"2022-05-27T12:11:18","date_gmt":"2022-05-27T10:11:18","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/introduction-a-la-formation-en-ligne-fda-21-cfr-part-11\/"},"modified":"2026-06-19T01:46:25","modified_gmt":"2026-06-18T23:46:25","slug":"introduction-a-la-formation-en-ligne-fda-21-cfr-part-11","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/introduction-a-la-formation-en-ligne-fda-21-cfr-part-11\/","title":{"rendered":"Introduction \u00e0 la FDA 21 CFR Part 11"},"content":{"rendered":"
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Ce cours permet aux apprenants d’acqu\u00e9rir une base solide sur les principes et les derni\u00e8res exigences applicables aux enregistrements \u00e9lectroniques dans le cadre de la FDA 21 CFR Part 11. La formation offre un aper\u00e7u des exigences de la FDA avec des exemples pratiques couvrant leur mise en oeuvre. Le cours aborde l’application de ces exigences aux syst\u00e8mes mat\u00e9riels et logiciels utilis\u00e9s dans la fabrication<\/a>, l’assurance qualit\u00e9, les affaires r\u00e9glementaires, la validation et la ma\u00eetrise des proc\u00e9d\u00e9s.<\/p>\n<\/div>\n

Ce cours propose une synth\u00e8se du sujet via une approche p\u00e9dagogique interactive. Ce contenu a \u00e9t\u00e9 \u00e9labor\u00e9 par une \u00e9quipe d’experts en affaires r\u00e9glementaires certifi\u00e9s par la Northeastern University de Boston, sous la direction d’un expert senior. <\/span><\/p>\n

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Contenu du cours :<\/h2>\n<\/div>\n

Introduction<\/strong><\/p>\n

Module 1 : Les r\u00e8gles de base (Predicate Rules)<\/strong><\/p>\n

    \n
  • Explication de la 21 CFR Part 11<\/li>\n
  • Enregistrements \u00e9lectroniques<\/li>\n
  • Que sont les r\u00e8gles de base ?<\/li>\n
  • Relation avec les r\u00e8gles de base<\/li>\n
  • R\u00e8gles de base et dossiers de lot<\/li>\n
  • Signatures \u00e9lectroniques<\/li>\n
  • Signatures manuscrites<\/li>\n<\/ul>\n

    Module 2 : Qu\u2019est-ce que la Part 11<\/strong><\/p>\n

      \n
    • Qu\u2019est-ce que la 21 CFR Part 11 ?<\/li>\n
    • Ligne directrice<\/li>\n
    • Champ d\u2019application restreint et application de la Part 11<\/li>\n
    • Les avantages<\/li>\n<\/ul>\n

      Module 3 : Explication des signatures et enregistrements \u00e9lectroniques<\/strong><\/p>\n

        \n
      • Signatures \u00e9lectroniques non impact\u00e9es<\/li>\n<\/ul>\n

         <\/p>\n

        Conclusion<\/strong><\/p>\n

        Examen final<\/strong><\/p>\n

        Certification<\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

        Ce cours permet aux apprenants d’acqu\u00e9rir une base solide sur les principes et les derni\u00e8res exigences applicables aux enregistrements \u00e9lectroniques dans le cadre de la FDA 21 CFR Part 11. La formation offre un aper\u00e7u des exigences de la FDA avec des exemples pratiques couvrant leur mise en oeuvre. Le cours aborde l’application de ces […]<\/p>\n","protected":false},"featured_media":59770,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[257,274,254,277,256,262,259,264,263,258],"product_tag":[],"class_list":{"0":"post-57160","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-hopitaux-et-etablissements-de-sante","12":"product_cat-laboratoires","13":"product_cat-transversal","14":"product_cat-organisme-de-recherche-sous-contrat-cro","15":"product_cat-pharmaceutique","17":"first","18":"instock","19":"taxable","20":"shipping-taxable","21":"purchasable","22":"product-type-subscription"},"bundled_by":["57838"],"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":"\nFormations en ligne et certification FDA 21 CFR PART 11<\/title>\n<meta name=\"description\" content=\"Formation en ligne FDA 21 CFR PART 11 avec certification. 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