{"id":6342,"date":"2026-03-07T22:25:12","date_gmt":"2026-03-08T03:25:12","guid":{"rendered":"https:\/\/mivado.com\/eshop\/?post_type=etn&#038;p=6342"},"modified":"2026-09-13T18:46:22","modified_gmt":"2026-09-13T22:46:22","slug":"process-performance-qualification","status":"publish","type":"etn","link":"https:\/\/mivado.com\/eshop\/m_event\/process-performance-qualification\/","title":{"rendered":"Validation des proc\u00e9d\u00e9s: Qualification de la performance des proc\u00e9d\u00e9s"},"content":{"rendered":"<p>Cette formation d&#8217;une journ\u00e9e sur la validation des proc\u00e9d\u00e9s vise \u00e0 pr\u00e9senter les concepts les plus r\u00e9cents en la mati\u00e8re. La FDA am\u00e9ricaine et l&#8217;EMA adoptent des approches diff\u00e9rentes. Comprendre ces approches est essentiel pour d\u00e9velopper et mettre en \u0153uvre des m\u00e9thodes de validation conformes et garantir la s\u00e9curit\u00e9 des produits fabriqu\u00e9s ou distribu\u00e9s.<\/p>\n<p>Ce programme de formation complet aborde les aspects critiques de la qualification des performances des proc\u00e9d\u00e9s (PPQ) dans l&#8217;industrie pharmaceutique. Il explore les exigences r\u00e9glementaires, les principes scientifiques et l&#8217;application pratique de la PPQ, permettant aux participants de planifier, r\u00e9aliser et documenter efficacement les \u00e9tudes de PPQ.<\/p>\n<p>La formation combine des pr\u00e9sentations, des \u00e9tudes de cas, des discussions interactives et des s\u00e9ances de questions-r\u00e9ponses.<\/p>\n<h2>Qui devrait participer\u00a0<\/h2>\n<p>Cette formation est con\u00e7ue pour les personnes impliqu\u00e9es dans la fabrication pharmaceutique, l&#8217;assurance qualit\u00e9, le contr\u00f4le qualit\u00e9, la recherche et le d\u00e9veloppement, ainsi que les affaires r\u00e9glementaires. Elle s&#8217;adresse notamment aux\u00a0:<\/p>\n<ul>\n<li>&#8211; Personnel de production<\/li>\n<li>&#8211; Personnel d&#8217;assurance qualit\u00e9<\/li>\n<li>&#8211; Sp\u00e9cialistes de la validation<\/li>\n<li>&#8211; Ing\u00e9nieurs de proc\u00e9d\u00e9s<\/li>\n<li>&#8211; Personnel des affaires r\u00e9glementaires<\/li>\n<li>&#8211; Personnel de laboratoire<\/li>\n<\/ul>\n<h2>Key Objectives<\/h2>\n<p><br \/>Upon completion of this training, participants will be able to:<\/p>\n<ul>\n<li>&#8211; Understand the regulatory framework governing PPQ (e.g., FDA, EMA guidelines).<\/li>\n<li>&#8211; Define PPQ and differentiate it from other validation activities (e.g., PQ, PV).<\/li>\n<li>\u00a0&#8211; Explain the importance of PPQ in ensuring consistent product quality.<\/li>\n<li>&#8211; Describe the key elements of a PPQ study design, including process characterization, critical process parameters (CPPs), and acceptance criteria.<\/li>\n<li>&#8211; Develop a robust PPQ protocol and report.<\/li>\n<li>&#8211; Understand the statistical approaches used in PPQ data analysis.<\/li>\n<li>&#8211; Effectively manage deviations and investigations during PPQ execution.<\/li>\n<li>&#8211; Apply risk management principles to PPQ.<\/li>\n<li>&#8211; Understand the lifecycle approach to PPQ, including continued process verification (CPV).<\/li>\n<li>&#8211; Be able to use AI tools to automate PPQ activities.<\/li>\n<\/ul>\n<h2>Training Schedule<\/h2>\n<ul>\n<li>&#8211; Introduction to Validation and PPQ<\/li>\n<li>&#8211; PPQ Planning and Preparation<\/li>\n<li>&#8211; PPQ Study Design and Protocol Development<\/li>\n<li>&#8211; Statistical Approaches in PPQ<\/li>\n<li>&#8211; PPQ Execution and Documentation<\/li>\n<li>&#8211; Continued Process Verification (CPV)<\/li>\n<li>&#8211; Risk Management in PPQ<\/li>\n<li>&#8211; Case Studies and Q&#038;A<\/li>\n<\/ul>\n<h2>Approche p\u00e9dagogique<\/h2>\n<ul>\n<li>&#8211; Les cours magistraux sont illustr\u00e9s par des exemples tir\u00e9s d&#8217;\u00e9tudes de cas.<\/li>\n<li>&#8211; Les exercices pratiques comprennent des exemples et des discussions.<\/li>\n<li>&#8211; Tout au long de la formation, la participation aux discussions et aux exercices sera \u00e9valu\u00e9e.<\/li>\n<li>&#8211; Un court questionnaire en fin de formation permettra d&#8217;\u00e9valuer la compr\u00e9hension des concepts cl\u00e9s par les participants.<\/li>\n<\/ul>\n<h2>\u00c0 qui s&#8217;adresse cette formation<\/h2>\n<p>Cette formation est con\u00e7ue pour les personnes impliqu\u00e9es dans la fabrication pharmaceutique, l&#8217;assurance qualit\u00e9, le contr\u00f4le qualit\u00e9, la recherche et le d\u00e9veloppement, ainsi que les affaires r\u00e9glementaires. Elle couvre notamment les domaines suivants\u00a0:<\/p>\n<ul>\n<li>&#8211; Personnel de production<\/li>\n<li>&#8211; Personnel d&#8217;assurance qualit\u00e9<\/li>\n<li>&#8211; Sp\u00e9cialistes de la validation<\/li>\n<li>&#8211; Ing\u00e9nieurs de proc\u00e9d\u00e9s<\/li>\n<li>&#8211; Personnel des affaires r\u00e9glementaires<\/li>\n<li>&#8211; Personnel de laboratoire<\/li>\n<\/ul>\n<h2>Mat\u00e9riels de formation<\/h2>\n<ul>\n<li>&#8211; Diapositives de pr\u00e9sentation<\/li>\n<li>&#8211; Documents reprenant les concepts cl\u00e9s et leurs d\u00e9finitions<\/li>\n<li>&#8211; \u00c9tudes de cas<\/li>\n<li>&#8211; Exemples de protocoles et de rapports PPQ<\/li>\n<li>&#8211; Lignes directrices r\u00e9glementaires pertinentes<\/li>\n<\/ul>\n<h2>Conf\u00e9rencier-Formateur<\/h2>\n<p><\/p>\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/ca.linkedin.com\/in\/kossi-molley-3534923\" target=\"_blank\" rel=\"noreferrer noopener\">Kossi Molley, chimiste; LSSBB; PMP; Formateur agr\u00e9\u00e9<\/a>\u00a0 \u00a0 \u00a0 \u00a0\u00a0<\/p>","protected":false},"excerpt":{"rendered":"<p>Ce programme de formation complet aborde les aspects critiques de la qualification des performances des proc\u00e9d\u00e9s (PPQ) dans l&#8217;industrie pharmaceutique. Il explore les exigences r\u00e9glementaires, les principes scientifiques et l&#8217;application pratique de la PPQ, permettant aux participants de planifier, r\u00e9aliser et documenter efficacement les \u00e9tudes de PPQ.<\/p>\n","protected":false},"author":2,"featured_media":6508,"parent":0,"template":"","etn_category":[26,198],"etn_tags":[200,31,203,201,37,202,38],"class_list":["post-6342","etn","type-etn","status-publish","has-post-thumbnail","hentry","etn_category-french","etn_category-webinar","etn_tags-capa","etn_tags-gmp","etn_tags-ppq","etn_tags-project-management","etn_tags-quality","etn_tags-quality-control","etn_tags-validation"],"tutor_lms_mapping":{},"_links":{"self":[{"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/etn\/6342","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/etn"}],"about":[{"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/types\/etn"}],"author":[{"embeddable":true,"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/users\/2"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/media\/6508"}],"wp:attachment":[{"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/media?parent=6342"}],"wp:term":[{"taxonomy":"etn_category","embeddable":true,"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/etn_category?post=6342"},{"taxonomy":"etn_tags","embeddable":true,"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/etn_tags?post=6342"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}