{"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":"2022-05-27T12:11:18","modified_gmt":"2022-05-27T10:11:18","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 formation en ligne FDA 21 CFR PART 11"},"content":{"rendered":"
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Les principaux objectifs de ce cours d\u2019e-learning sont de donner aux apprenants une base sur les principes et les derni\u00e8res exigences relatives aux enregistrements \u00e9lectroniques concernant la norme FDA 21 CFR PART 11. La formation offre un aper\u00e7u des exigences de la FDA avec des exemples pratiques couvrant la mise en \u0153uvre de ces exigences. Le cours traite de l\u2019application de ces exigences aux syst\u00e8mes mat\u00e9riels et logiciels utilis\u00e9s dans la fabrication<\/a>, l\u2019assurance qualit\u00e9, les affaires r\u00e9glementaires, la validation et le contr\u00f4le des processus. <\/p>\n<\/div>\n

Dans ce cours, nous proposons une synth\u00e8se du sujet \u00e0 travers une exp\u00e9rience interactive en ligne. Ce mat\u00e9riel a \u00e9t\u00e9 con\u00e7u par une \u00e9quipe d\u2019experts en affaires r\u00e9glementaires dipl\u00f4m\u00e9s de l\u2019Universit\u00e9 Northeastern de Boston, pilot\u00e9e par un membre senior capable d\u2019articuler la th\u00e9orie avec la pratique. <\/span><\/p>\n

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Programme :<\/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":"

        Les principaux objectifs de ce cours d\u2019e-learning sont de donner aux apprenants une base sur les principes et les derni\u00e8res exigences relatives aux enregistrements \u00e9lectroniques concernant la norme FDA 21 CFR PART 11. La formation offre un aper\u00e7u des exigences de la FDA avec des exemples pratiques couvrant la mise en \u0153uvre de ces exigences. […]<\/p>\n","protected":false},"featured_media":42859,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[257,274,254,277,256,262,259,263,258,264],"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-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":"\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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