{"id":2301,"date":"2023-09-20T20:32:21","date_gmt":"2023-09-21T00:32:21","guid":{"rendered":"https:\/\/www.gxpconseils.com\/?page_id=2301"},"modified":"2023-09-30T10:31:13","modified_gmt":"2023-09-30T14:31:13","slug":"qualite-conformite","status":"publish","type":"page","link":"https:\/\/www.gxpconseils.com\/en\/qualite-conformite\/","title":{"rendered":"Qualit\u00e9-Conformit\u00e9"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"2301\" class=\"elementor elementor-2301\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-9a95676 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle elementor-invisible\" data-id=\"9a95676\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-55fe64d\" data-id=\"55fe64d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-f3ab045 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f3ab045\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-eecb3a6\" data-id=\"eecb3a6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c0b8f0d elementor-widget elementor-widget-button\" data-id=\"c0b8f0d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.gxpconseils.com\/en\/#Expertises2\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Back<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c67757c elementor-widget elementor-widget-text-editor\" data-id=\"c67757c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Based on our extensive experience , knowledge and understanding of FDA, HC, EMA and ICH regulations and guidelines, we perform for our customers:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-4eec10a elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"4eec10a\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-bbcdcc3\" data-id=\"bbcdcc3\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-86f9d20 elementor-view-default elementor-position-block-start elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"86f9d20\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-edit\"><\/i>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tQuality\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-44869bf elementor-widget elementor-widget-text-editor\" data-id=\"44869bf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>Temporary replacement of a senior quality manager<\/li><li>Implementation of a quality management system adapted to the size of your company<\/li><li>Development, implementation and monitoring of the following Quality programs and processes:<ul><li style=\"list-style-type: none;\"><ul><li>Training program<\/li><li>Deviation program, change control and CAPAs<\/li><li>Risk analysis program<\/li><li>Risk-based supplier qualification program<\/li><li>Environmental monitoring program<\/li><li>Product stability program<\/li><\/ul><\/li><\/ul><\/li><li>Quality process optimization<\/li><li>Drafting of Quality Manuals\/Site Master Documents and procedures<\/li><li>Management of eQMS acquisition and implementation phases<\/li><li>Selection and qualification of suppliers, CMO\/TPLs<\/li><li>QA review of protocols\/validation reports\/qualifications<\/li><li>Operational design in compliance with regulatory requirements and start-up of QC laboratories<\/li><li>Drafting and review of QC-analytical, bioanalytical and microbiological validation\/transfer protocols<\/li><li>Review of batch records<\/li><li>Quality management system training such as BPx training (GMP, GCP, GDP, etc.)<\/li><li>Coaching and Mentoring<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-84c0cbf\" data-id=\"84c0cbf\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-642dc46 elementor-view-default elementor-position-block-start elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"642dc46\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-check-square\"><\/i>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tCompliance\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e0aa049 elementor-widget elementor-widget-text-editor\" data-id=\"e0aa049\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>FDA, HC and EMA regulatory inspections:<ul><li>GAP analysis against regulatory requirements<\/li><li>Implementation of an inspection management system (preparation of rooms and communications systems, training, EMS coaching, etc.)<\/li><li>Assist during inspections to prepare response strategies and coaching of SMEs<\/li><li>Development of corrective plans required as a result of these inspections<\/li><li>Support the preparation of responses to regulatory agencies<\/li><\/ul><\/li><li>Perform audits of suppliers, manufacturers, packagers, laboratories (GMP and GLP) and distributors.<\/li><li>Perform audits of clinical sites (GCP)<\/li><li>Support the conduct of major and critical investigations<\/li><li>Perform site maturity analysis and CMC dossier for FDA, HC or EMA pre-licensing inspection of product, PLI or PAI<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Retour Bas\u00e9 sur notre vaste exp\u00e9rience et notre connaissance et compr\u00e9hension approfondie de la r\u00e9glementation et des lignes directrices de la FDA, SC, EMA et ICH, nous effectuons pour nos clients : Qualit\u00e9 Remplacement temporaire de gestionnaire s\u00e9nior en Qualit\u00e9 Implantation d`un syst\u00e8me de gestion de la qualit\u00e9 adapt\u00e9 \u00e0 la taille de votre entreprise. [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-2301","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Qualit\u00e9-Conformit\u00e9 - GxP Conseils<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.gxpconseils.com\/en\/qualite-conformite\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Qualit\u00e9-Conformit\u00e9 - GxP Conseils\" \/>\n<meta property=\"og:description\" content=\"Retour Bas\u00e9 sur notre vaste exp\u00e9rience et notre connaissance et compr\u00e9hension approfondie de la r\u00e9glementation et des lignes directrices de la FDA, SC, EMA et ICH, nous effectuons pour nos clients : Qualit\u00e9 Remplacement temporaire de gestionnaire s\u00e9nior en Qualit\u00e9 Implantation d`un syst\u00e8me de gestion de la qualit\u00e9 adapt\u00e9 \u00e0 la taille de votre entreprise. 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