{"id":3814,"date":"2023-05-10T14:27:27","date_gmt":"2023-05-10T12:27:27","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/uncategorized\/analytical-results-oos-ooe-oot\/"},"modified":"2026-06-05T11:56:23","modified_gmt":"2026-06-05T09:56:23","slug":"analytical-results-oos-ooe-oot","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/quality-and-process\/analytical-results-oos-ooe-oot\/","title":{"rendered":"The Investigation of Out-of-Specification (OOS) and Out of Trend (OOE\/OOT) Analytical Results"},"content":{"rendered":"<p><strong>Part One &#8211; The investigation of out-of-specification and unexpected results<br \/>\n<\/strong><\/p>\n<p>The training course &#8220;The Investigation of Out-of-Specification (OOS) and Out of Trend (OOE\/OOT) Analytical Results&#8221; aims to provide the tools to identify and classify anomalies found in analytical data that may constitute an out-of-specification, out-of-trend, or unexpected finding. In the first part of the training, we will focus on how to conduct a structured survey and perform an effective RCA aimed at identifying the actual root cause. Besides, throughout the day, regulatory references will be provided and the proper requirements for an investigation that is in compliance with regulatory expectations will be explained in depth, providing examples from the literature.<\/p>\n<p><strong>Part Two &#8211; The CAPA plan, OOS in stability data\u00a0<\/strong><strong>management and from supplier<br \/>\n<\/strong><\/p>\n<p><span style=\"font-size: 16px;\">In the second part of the course &#8220;The Investigation of Out-of-Specification (OOS) and Out of Trend (OOE\/OOT) Analytical Results&#8221; having acquired during the first part the necessary concepts for conducting a laboratory investigation related to out-of-specification results, we will focus on the management of the outlier data and its impact on the process\/product. How to define an appropriate CAPA plan and effectiveness check will be examined. Then OOS results generated by third parties (suppliers, CMOs, analytical service providers) and the necessary actions (CAPA plan and follow up) towards suppliers will be addressed. In addition, OOS results from stability and consequent actions on the process\/product and evaluation of regulatory impacts will be addressed.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The training course &#8220;The Investigation of Out-of-Specification (OOS) and Out of Trend (OOE\/OOT) Analytical Results&#8221; aims to provide the tools to identify and classify anomalies found in analytical data that may constitute an out-of-specification, out-of-trend, or unexpected finding.<\/p>\n","protected":false},"featured_media":3139,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"default","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":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","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":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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2\r\n\r\n<strong>Part 1: The investigation of out-of-specification and unexpected outcomes<\/strong>\r\n\r\nIntroduction:\r\n<ul>\r\n \t<li>Course presentation, purpose, expectations<\/li>\r\n \t<li>Specific definitions and terminology<\/li>\r\n<\/ul>\r\nRegulatory references and requirements:\r\n<ul>\r\n \t<li>What GMP requires when dealing with out-of-specification results<\/li>\r\n \t<li>Presentation of the MHRA guideline<\/li>\r\n \t<li>FDA guideline presentation<\/li>\r\n \t<li>Sample observations from regulatory audits pertaining to investigation of OOS results<\/li>\r\n<\/ul>\r\nThe laboratory investigation:\r\n<ul>\r\n \t<li>Initial investigation<\/li>\r\n \t<li>Officialization of the OOS data<\/li>\r\n \t<li>Management of related batches<\/li>\r\n \t<li>Conclusion of the laboratory investigation<\/li>\r\n<\/ul>\r\nThe extended investigation:\r\n<ul>\r\n \t<li>Root causes analysis: methodologies and tools<\/li>\r\n \t<li>Modalities of in-depth laboratory investigation<\/li>\r\n \t<li>When and how to conduct an interdepartmental investigation<\/li>\r\n \t<li>Evaluation of survey data and conclusion<\/li>\r\n<\/ul>\r\nThe survey of OOE\/OOT data\r\n\r\nDiscussion and questions\r\n\r\n&nbsp;\r\n\r\n<strong>Part 2: The CAPA plan, OOS data management in stability and from supplier<\/strong>\r\n\r\n09:00 \u2013 13:00 COURSE SESSION\r\n\r\nNonconformity from Supplier:\r\n<ul>\r\n \t<li>Management of abnormal results obtained on raw materials, intermediates or SMF\/PF prepared by external workshops<\/li>\r\n \t<li>Management of abnormal results obtained from external laboratories performing commissioned analysis<\/li>\r\n \t<li>Follow-up of CAPA plans defined and implemented by the supplier<\/li>\r\n \t<li>Impact on risk factor and audit plan<\/li>\r\n<\/ul>\r\nAnomalous data in stability studies: investigation and FAR (field alert report)\r\n<ul>\r\n \t<li>Impact on the process\/product<\/li>\r\n \t<li>FAR (field alert report) for the US market.<\/li>\r\n \t<li>Assessment of regulatory impacts<\/li>\r\n<\/ul>\r\nCAPA plan definition:\r\n<ul>\r\n \t<li>Periodical review: periodic trends in OOS and OOTs<\/li>\r\n \t<li>dentification and analysis of root causes<\/li>\r\n \t<li>Identification of immediate corrective actions and actions to remove root causes<\/li>\r\n \t<li>Plan for monitoring the effectiveness of CAPA action plans<\/li>\r\n<\/ul>\r\nDiscussion and questions\r\n\r\nTest with correction","corso_target":"Quality Control, Quality Assurance, Validation team, Chemical and formulation development, Production, Regulatory Affairs, Engineering, Supply Chain.","corso_competenze":[{"corso_competenze_item":"Identify and classify out-of-specification and abnormal results"},{"corso_competenze_item":"Know the relevant regulations for handling OOS results"},{"corso_competenze_item":"How to conduct a structured and effective investigation"},{"corso_competenze_item":"Highlight on recurring regulatory observations (examples)"},{"corso_competenze_item":"Manage nonconformities obtained on materials\/products\/analyses provided by external agencies"},{"corso_competenze_item":"Manage OOS obtained from stability studies"},{"corso_competenze_item":"Setting up an effective CAPA plan"},{"corso_competenze_item":"Monitoring the effectiveness of the CAPA plan (effectiveness check)"}]},"_links":{"self":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product\/3814","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media\/3139"}],"wp:attachment":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media?parent=3814"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_brand?post=3814"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_cat?post=3814"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_tag?post=3814"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}