{"id":16670,"date":"2022-12-19T13:09:14","date_gmt":"2022-12-19T12:09:14","guid":{"rendered":"https:\/\/www.maghrebpharma.com\/track-1-qualification-validation-statistical-process-control-and-industrial-performance\/"},"modified":"2023-01-17T09:22:34","modified_gmt":"2023-01-17T08:22:34","slug":"track-1-qualification-validation-statistical-process-control-and-industrial-performance","status":"publish","type":"page","link":"https:\/\/www.maghrebpharma.com\/en\/track-1-qualification-validation-statistical-process-control-and-industrial-performance\/","title":{"rendered":"Track 1 – Qualification, validation, statistical process control and industrial performance"},"content":{"rendered":"\t\t
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MASTER CLASS MAGHREB PHARMA 2023<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Wednesday, February 8, 2023<\/h2>\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
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Track 1 - Qualification, validation, statistical process control and industrial performance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\tMr. Pierre DEVAUX\r\n\r\nDirector of Theraxel and Isotec’xel\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
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  • Topic: “Overview New Annex 1 of the European GMPs: Key issues and the link with the concepts of Control and Monitoring for manufacturing sites of sterile and related products”.<\/li>\r\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    • Cette pr\u00e9sentation se veut une vision tr\u00e8s pratique de l\u2019Annexe 1 en y incluant les attentes des Autorit\u00e9s de Sant\u00e9 en d\u00e9crivant le processus de r\u00e9vision qui l\u2019a accompagn\u00e9.\r\nAu-del\u00e0 de cette pr\u00e9sentation, il sera bien \u00e9videmment possible d\u2019\u00e9changer sur l\u2019ensemble du document.\r\nCette pr\u00e9sentation apportera notamment du conseil sur l\u2019\u00e9laboration de votre CCS, nouveau document exig\u00e9 par les Autorit\u00e9s de Sant\u00e9 europ\u00e9ennes.<\/li>\r\n<\/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
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      \n\t\t\t\t\t\t\t\t\tMr. Jean-Louis JOUVE\r\n\r\nPresident and owner of COETIC SAS\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
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      • Topic : “CSV: Validation of Computerised Systems in the Pharmaceutical Industry.<\/li>\r\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        • The requirement for validation of computerised systems is widely known, but how can this validation be implemented effectively and efficiently, taking into account the multiplicity of systems, suppliers, available documentation and changing technologies? Can new approaches such as Computer Software Assurance (CSA) help industry?<\/li>\r\n<\/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
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          \n\t\t\t\t\t\t\t\t\tPharmD Malik METAHRI\r\n\r\nManaging Director & Senior Partner, ACG – Accelerator Consulting Group (Europe & Middle East) | President of A3P Egypt & Middle East<\/strong>\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
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          • Topic : ” EMA and FDA certification: Strategy and standards for preparing and managing regulatory inspections “<\/li>\r\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            • Abstract coming soon<\/li>\r\n<\/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
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              • Topic “APR: A regulatory tool for monitoring process performance”<\/li>\r\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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                • The pharmaceutical industry is an industry subject to intensified and constantly updated quality and regulatory requirements. This rigour in the production of pharmaceutical products has made it possible to master the pharmaceutical processes. As a result, a summary report is produced annually for each product placed on the market, known as the Annual Product Quality Review (APQR).\r\nIndeed, the APQR is much more than a simple response to regulatory requirements but a major process in the improvement of product and process quality. It is a real tool of the quality management system and is an indispensable element within a pharmaceutical company.\r\nIt is a tool for monitoring the quality of products over the years, which ensures the control of the manufacturing process by following trends, anticipating deviations, and evaluating the specifications, the manufacturing method, and the control of the product on the one hand, and on the other hand, to highlight failures in the system in order to allow an annual evaluation of its level of efficiency and performance.<\/li>\r\n<\/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
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                  • Topic : “Implementation of the visual performance management system”<\/li>\r\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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                    • Industrial performance is a major objective of any company, the declination of strategic objectives into a performance management system and its implementation down to the shop floor level is based on management components such as\r\n– The implementation of the industrial KPI system\r\n– Visual performance management\r\n– Short interval animation and the Daily management system\r\n– Structured problem solving system.\r\nIn this paper, the different components of this system will be discussed, as well as the steps to implement the system and the key success factors of this system. The benefits of our joint approach :\r\n– Ritualised performance management with a system of escalations\r\n– Standardisation of practices for all managers\r\n– Easier reporting and transmission of problems in the field\r\n– Prioritisation and follow-up of actions generated\r\n– Empowerment of employees thanks to an integrated “problem-solving” application aid.<\/li>\r\n<\/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
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                      \n\t\t\t\t\t\t\t\t\tDr. Nazim BERERHI\r\n\r\nConsultant, Trainer, Auditor on ISO 9001 standard\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
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                      • Topic : “Management system: how to prepare and conduct a management review”.<\/li>\r\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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                        • In a world where the stakes are constantly changing, and which impact the operation, performance and sustainability of the company. ISO 9001 provides companies with a quality management system, with the objective of ensuring the conformity of products to legal requirements but also to increase customer satisfaction.\r\nThrough the development of the risk approach, continuous improvement and the process approach, ISO 9001 enables the various risks and opportunities to be controlled and added value to be created in all processes in order to achieve the objectives.\r\nTo this end, management must review the entire system, its operation, its performance, its results and the various feedbacks at planned intervals through the management review,\r\nIn our workshop, we will develop the different aspects of this review, the methods of data collection, consolidation and analysis of information, but also how to define the most interesting interval for a good exploitation of this review as a tool for improving the system and the objectives.\r\nMore than just inputs, the management review will allow, through the development of a factual and methodical approach, to make the right decisions and to determine the resource needs and opportunities for improvement.<\/li>\r\n<\/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
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                          MASTER CLASS MAGHREB PHARMA 2023 Wednesday, February 8, 2023 Book your seat Track 1 – Qualification, validation, statistical process control and industrial performance Mr. Pierre DEVAUX Director of Theraxel and Isotec’xel09h00 – 10h30 Topic: “Overview New Annex 1 of the European GMPs: Key issues and the link with the concepts of Control and Monitoring for […]<\/p>\n","protected":false},"author":82,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_seopress_robots_primary_cat":"","_seopress_titles_title":"Track 1 - Qualification, validation, statistical process control and industrial performance","_seopress_titles_desc":"MASTER CLASS Maghreb Pharma on \" Qualification, validation, statistical control of processes and industrial performance\"","_seopress_robots_index":"","footnotes":""},"class_list":["post-16670","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.maghrebpharma.com\/en\/wp-json\/wp\/v2\/pages\/16670","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.maghrebpharma.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.maghrebpharma.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.maghrebpharma.com\/en\/wp-json\/wp\/v2\/users\/82"}],"replies":[{"embeddable":true,"href":"https:\/\/www.maghrebpharma.com\/en\/wp-json\/wp\/v2\/comments?post=16670"}],"version-history":[{"count":0,"href":"https:\/\/www.maghrebpharma.com\/en\/wp-json\/wp\/v2\/pages\/16670\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.maghrebpharma.com\/en\/wp-json\/wp\/v2\/media?parent=16670"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}