{"id":3922,"date":"2021-08-10T08:55:15","date_gmt":"2021-08-10T12:55:15","guid":{"rendered":"https:\/\/web.uri.edu\/pdi\/?page_id=3922"},"modified":"2023-07-20T08:50:49","modified_gmt":"2023-07-20T12:50:49","slug":"validation-concepts-in-biopharmaceutical-manufacturing","status":"publish","type":"page","link":"https:\/\/web.uri.edu\/pdi\/training\/validation-concepts-in-biopharmaceutical-manufacturing\/","title":{"rendered":"Validation Concepts in Biopharmaceutical Manufacturing"},"content":{"rendered":"<section class=\"cl-wrapper cl-hero-wrapper\"><div class=\"cl-hero   cl-has-accessibility-controls\"><div class=\"cl-hero-proper\"><div class=\"overlay\"><div class=\"block\"><h1>Validation Concepts in Biopharmaceutical Manufacturing<\/h1><p>Participants explore the history of validation, the approaches of validation, and what equipment must be validated<\/p><\/div><\/div><div class=\"still\" style=\"background-image:url(https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/validation-scaled.jpg);\"><\/div><div class=\"cl-accessibility-controls-container\"><div class=\"cl-accessibility-controls\"><div class=\"cl-accessibility-icon\" title=\"Accessibility controls\">Accessibility controls<\/div><div class=\"cl-accessibility-control cl-accessibility-motion-control cl-accessibility-control-hidden\"><div class=\"cl-accessibility-control-default\"><div class=\"cl-accessibility-control-button\" title=\"Pause motion\">Pause motion<\/div><div class=\"cl-accessibility-control-label\">Motion: <span class=\"cl-accessibility-syntax\">On<\/span><\/div><\/div><div class=\"cl-accessibility-control-alternate\"><div class=\"cl-accessibility-control-button\" title=\"Play motion\">Play motion<\/div><div class=\"cl-accessibility-control-label\">Motion: <span class=\"cl-accessibility-syntax\">Off<\/span><\/div><\/div><\/div><div class=\"cl-accessibility-control cl-accessibility-contrast-control\"><div class=\"cl-accessibility-control-default\"><div class=\"cl-accessibility-control-button\" title=\"Increase text contrast\">Increase text contrast<\/div><div class=\"cl-accessibility-control-label\">Contrast: <span class=\"cl-accessibility-syntax\">Standard<\/span><\/div><\/div><div class=\"cl-accessibility-control-alternate\"><div class=\"cl-accessibility-control-button\" title=\"Reset text contrast\">Reset text contrast<\/div><div class=\"cl-accessibility-control-label\">Contrast: <span class=\"cl-accessibility-syntax\">High<\/span><\/div><\/div><\/div><div class=\"cl-accessibility-system-setting\"><div class=\"cl-accessibility-toggle\" title=\"Apply my preferences site-wide\"><\/div><div class=\"cl-accessibility-toggle-label\">Apply site-wide<\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<div class=\"cl-wrapper cl-boxout-wrapper\"><div class=\"cl-boxout right  \"><h1>Want to know more?<\/h1><p><b>Email <a href=\"mailto:pdi@etal.uri.edu\">pdi@etal.uri.edu<\/a><br \/>\nor call 401.874.3114<\/b><br \/>\n<\/p><\/div><\/div>\n<p><span data-contrast=\"auto\">The course covers the fundamentals and importance of all aspects of validation with a focus on equipment validation (IQ and OQ) in the manufacturing of biopharmaceuticals and gain hands-on experience with temperature mapping and analysis of mapping data of critical equipment.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">&nbsp;<\/span><\/p>\n<p><span data-contrast=\"auto\">Participants gain knowledge in the history of validation, the approaches of validation, and what equipment must be validated.\u202f The course covers the fundamentals and importance of all aspects of validation with a focus on equipment validation (IQ and OQ) in the manufacturing of biopharmaceuticals and gain hands-on experience with temperature mapping and analysis of mapping data of critical equipment.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">&nbsp;<\/span><\/p>\n<section class=\"cl-wrapper cl-panel-wrapper\"><div class=\"cl-panel reverse  \"><figure><img decoding=\"async\" src=\"https:\/\/web.uri.edu\/wp-content\/uploads\/sites\/1340\/cropped-cropped-blue-surf.jpg\" srcset=\"\" alt=\"cropped-cropped-blue-surf.jpg\"><\/figure><article><h1>Objectives<\/h1><p><\/p>\n<ul>\n<li>Attain knowledge about the history of validation and how to validate equipment.<\/li>\n<li>Understand the fundamentals and importance of validation, including IQ and OQ, needed for biopharmaceutical manufacturing.<\/li>\n<li>Perform hands-on techniques including temperature mapping, including pre-calibration, and analysis of the mapped data from critical equipment.<\/li>\n<\/ul>\n<p><\/p><\/article><\/div><\/section>\n<h1>Who should attend this course?<\/h1>\n<p><span class=\"TextRun SCXW224685583 BCX8\" lang=\"EN\" xml:lang=\"EN\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW224685583 BCX8\">Course work and laboratory exercises are designed for individuals working in the <\/span><span class=\"NormalTextRun SCXW224685583 BCX8\">b<\/span><span class=\"NormalTextRun SCXW224685583 BCX8\">iomanufacturing industry including roles such as Upstream and Downstream Technicians, Quality Assurance, Quality Control, Bioprocess Engineers, Facilities<\/span><span class=\"NormalTextRun SCXW224685583 BCX8\">,<\/span><span class=\"NormalTextRun SCXW224685583 BCX8\"> and Plant Operations<\/span><span class=\"NormalTextRun SCXW224685583 BCX8\">.<\/span><\/span><span class=\"EOP SCXW224685583 BCX8\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">&nbsp;<\/span><\/p>\n<section class=\"cl-wrapper cl-panel-wrapper\"><div class=\"cl-panel  \"><figure><img decoding=\"async\" src=\"https:\/\/web.uri.edu\/wp-content\/uploads\/sites\/1340\/cropped-cropped-blue-surf.jpg\" srcset=\"\" alt=\"cropped-cropped-blue-surf.jpg\"><\/figure><article><h1>Delivery<\/h1><p>In-person lectures and hands on activities in a simulated GMP facility.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/p>\n<ul>\n<li>Duration: 1.5 Days<\/li>\n<li>Time: Day 1: 8:00am to 4:00pm, Day 2: 8:00am &#8211; noon<\/li>\n<li>Location: Kingston, RI<\/li>\n<li>Max Number of Participants: 15<\/li>\n<\/ul>\n<p><\/p><\/article><\/div><\/section>\n<h3>&nbsp;<\/h3>\n<h1>Instructors<\/h1>\n<\/p>\n<div class=\"uri-people-tool cl-tiles halves\"><div class=\"peopleitem h-card has-thumbnail\">\n\t<header>\n\t\t<div class=\"header\">\n\t\t\t\t\t\t<figure>\n\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/web.uri.edu\/pdi\/meet\/jennifer-lewis\/\"><img loading=\"lazy\" decoding=\"async\" width=\"200\" height=\"200\" src=\"https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/Jen-LinkedIn-Photo.jpg\" class=\"u-photo  wp-post-image\" alt=\"\" srcset=\"https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/Jen-LinkedIn-Photo.jpg 200w, https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/Jen-LinkedIn-Photo-150x150.jpg 150w\" sizes=\"auto, (max-width: 200px) 100vw, 200px\" \/><\/a>\n\t\t\t\t\t\t\t<\/figure>\n\t\t\t\n\t\t\t\t\t\t\t<h3 class=\"p-name\"><a href=\"https:\/\/web.uri.edu\/pdi\/meet\/jennifer-lewis\/\">Jennifer Lewis, Ph.D.<\/a><\/h3>\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t<\/header>\n\t<div class=\"inside\">\n\n\t\t<p class=\"people-title p-job-title\">Associate Director Analytical Development\/QC <\/p>\n\t\t\n\t\t\t\t<p class=\"people-department\">Avedisian Hall 395L<\/p>\n\t\t\n\t\t\n\t\t\t\t\t<p class=\"people-misc\"><span class=\"p-tel\">401.874.9093<\/span> <br> <a class=\"u-email\" href=\"mailto:jenlewis@uri.edu\">jenlewis@uri.edu<\/a><\/p>\n\t\t\n\t\t<div style=\"clear:both;\"><\/div>\n\t<\/div>\n<\/div>\n<\/div>\n<p>\n<h1>Content Outline<\/h1>\n<h2>Day 1<\/h2>\n<ol>\n<li>History of Validation<\/li>\n<li>What is Validation\/Regulation Overview<\/li>\n<li>Validation Disciplines Overview<\/li>\n<li>When Do You Validate and How<\/li>\n<li>Basics of Equipment Validation<\/li>\n<li>Installation Qualification Overview<\/li>\n<li>Operational Qualification Overview<\/li>\n<li>Temperature Mapping Exercise\n<ul>\n<li>TC Pre Calibration<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<h2>Day 2<\/h2>\n<ol>\n<li>Temperature Mapping Exercise continued\n<ul>\n<li>Thermal Mapping<\/li>\n<li>Breakdown of Equipment<\/li>\n<li>TC Post Verification<\/li>\n<\/ul>\n<\/li>\n<li>Group Breakouts for Analysis of All Data<\/li>\n<li>Team Review of Data<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; &nbsp; The course covers the fundamentals and importance of all aspects of validation with a focus on equipment validation (IQ and OQ) in the manufacturing of biopharmaceuticals and gain hands-on experience with temperature mapping and analysis of mapping data of critical equipment.&nbsp; Participants gain knowledge in the history of validation, the approaches of validation, [&hellip;]<\/p>\n","protected":false},"author":639,"featured_media":0,"parent":2234,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-3922","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/pages\/3922","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/users\/639"}],"replies":[{"embeddable":true,"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/comments?post=3922"}],"version-history":[{"count":5,"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/pages\/3922\/revisions"}],"predecessor-version":[{"id":4562,"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/pages\/3922\/revisions\/4562"}],"up":[{"embeddable":true,"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/pages\/2234"}],"wp:attachment":[{"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/media?parent=3922"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}