{"id":3947,"date":"2023-05-08T14:52:39","date_gmt":"2023-05-08T12:52:39","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/uncategorized\/apr-pqr-capa-system\/"},"modified":"2026-02-04T10:13:48","modified_gmt":"2026-02-04T09:13:48","slug":"apr-pqr-capa-system","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/quality-and-process\/apr-pqr-capa-system\/","title":{"rendered":"Training on APR-PQR and CAPA System"},"content":{"rendered":"<p>The training course &#8220;APR, PQR and CAPA System&#8221; is structured in two parts: the first will explain the current regulatory requirements (EU &#8211; FDA) for the issuance of PQR and APR reports with a detailed description of the contents of the individual chapters, as well as the organizational flow, timing, definition of the actors involved and the collection of supporting data to ensure effective and timely issuance of the document, in compliance with regulatory requirements.<\/p>\n<p>The explanation will be followed by a complete example of PQR, with comments on the main contents of the individual chapters and insights directed at highlighting tools for &#8220;Continuous Improvement.&#8221;<\/p>\n<p>In the second part of the course, on the other hand, the CAPA Management System and the management of Deviations as an integral part of Quality System Management will be explained.<\/p>\n<p><strong>Would you like to participate, but you&#8217;re not available on this date?<\/strong><br \/>\nThe course will be provided again:<\/p>\n<ul>\n<li>November 20th 2024<\/li>\n<li>May 14th 2025<\/li>\n<\/ul>\n<p>(*) Contact us via email or phone to enroll.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The training course &#8220;APR, PQR and CAPA System&#8221; is structured in two parts: the first will explain the current regulatory requirements (EU &#8211; FDA) for the issuance of PQR and APR reports with a detailed description of the contents of the individual chapters, as well as the organizational flow, timing, definition of the actors involved and the collection of supporting data to ensure effective and timely issuance of the document, in compliance with regulatory 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SESSION\r\n<ul>\r\n \t<li>EU, US and ICH regulatory requirements, definition of responsibilities and role of APQR in Quality Management System<\/li>\r\n \t<li>How to efficiently structure data collection, timing, definition of actors involved, merging criteria and rationales<\/li>\r\n \t<li>APQR chapters: complete example of an APQR with comments on the main contents of individual chapters<\/li>\r\n \t<li>CAPA Management System: overview of cGMP requirements and EMA-FDA Guidelines<\/li>\r\n \t<li>CAPA: sources, critical steps and example of a CAPA form<\/li>\r\n \t<li>Deviations: introductory hints and relationship between CAPA and deviations<\/li>\r\n<\/ul>","corso_target":"Personnel involved in the areas of Quality Assurance, Quality Control, Compliance and Operations.","corso_competenze":[{"corso_competenze_item":"Understand the importance of APR\/PQR reports"},{"corso_competenze_item":"Know the regulatory requirements for the Europe and U.S. 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