{"id":3925,"date":"2021-08-10T09:00:00","date_gmt":"2021-08-10T13:00:00","guid":{"rendered":"https:\/\/web.uri.edu\/pdi\/?page_id=3925"},"modified":"2023-07-20T08:53:13","modified_gmt":"2023-07-20T12:53:13","slug":"quality-compliance-systems","status":"publish","type":"page","link":"https:\/\/web.uri.edu\/pdi\/training\/quality-compliance-systems\/","title":{"rendered":"Quality\/Compliance Systems"},"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>Quality\/Compliance Systems<\/h1><p>Participants gain knowledge of Quality Management Systems, explore aspects of the principles and responsibilities of a quality unit, understand the role quality assurance plays across functional areas and the importance of a quality culture<\/p><\/div><\/div><div class=\"still\" style=\"background-image:url(https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/quality.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 class=\"TextRun SCXW160338088 BCX8\" lang=\"EN\" xml:lang=\"EN\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW160338088 BCX8\">Participants will learn the fundamentals and importance of a robust compliance program and gain hands-on experience performing a mock compliance audit.<\/span><\/span><span class=\"EOP SCXW160338088 BCX8\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\">&nbsp;<\/span><\/p>\n<p class=\"cl-panel-spacer\"><span class=\"TextRun SCXW1129581 BCX8\" lang=\"EN\" xml:lang=\"EN\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW1129581 BCX8\">P<\/span><span class=\"NormalTextRun SCXW1129581 BCX8\">articipants <\/span><span class=\"NormalTextRun SCXW1129581 BCX8\">gain knowledge in <\/span><span class=\"NormalTextRun SCXW1129581 BCX8\">Quality Management Systems, explore aspects of the principles and responsibilities of a quality unit, understand the role quality assurance plays across functional areas and the importance of a quality culture.\u202f Participants will learn the fundamentals and importance of a robust compliance program and gain hands-on experience performing a mock compliance audit.<\/span><\/span><span class=\"EOP SCXW1129581 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 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 quality, including regulations, guidelines, and the role of agencies.<\/li>\n<li>Learn how to build a Quality Management System with a quality culture and explore ICH Q10.<\/li>\n<li>Explore aspects of principles and responsibilities of a quality unit.<\/li>\n<li>Learn about the cost of poor quality in the product development lifecycle.<\/li>\n<li>Perform mock compliance audit to understand fundamentals and importance of a robust compliance program.<\/li>\n<\/ul>\n<p><\/p><\/article><\/div><\/section>\n<h1>Who should attend this course?<\/h1>\n<p><span class=\"TextRun SCXW185538171 BCX8\" lang=\"EN\" xml:lang=\"EN\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW185538171 BCX8\">Course work and laboratory exercises are designed for individuals working in the <\/span><span class=\"NormalTextRun SCXW185538171 BCX8\">b<\/span><span class=\"NormalTextRun SCXW185538171 BCX8\">iomanufacturing industry including roles such as Upstream and Downstream Technicians, Quality Assurance, Quality Control, Bioprocess Engineers, Facilities<\/span><span class=\"NormalTextRun SCXW185538171 BCX8\">,<\/span><span class=\"NormalTextRun SCXW185538171 BCX8\"> and Plant Operations<\/span><span class=\"NormalTextRun SCXW185538171 BCX8\">.<\/span><\/span><span class=\"EOP SCXW185538171 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.<\/p>\n<ul>\n<li>Duration: 1.5 Days<\/li>\n<li>Time: Day 1: 8:00am to 4:00pm<br \/>\nDay 2: 8:00am \u2013 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<ol>\n<li>History of Quality<\/li>\n<li>Regulations\/Guidelines\/Role of Agencies<\/li>\n<li>Principle Roles and Responsibilities of the Quality Unit<\/li>\n<li>ICH Q10 and Quality Management Systems<\/li>\n<li>Quality Culture<\/li>\n<li>The Cost of Poor Quality<\/li>\n<li>Quality and the Product Development Lifecycle<\/li>\n<li>Fundamentals of Compliance\n<ul>\n<li>Auditing basics<\/li>\n<li>Mock Compliance Audit<\/li>\n<li>Review of Audit Findings<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; &nbsp; Participants will learn the fundamentals and importance of a robust compliance program and gain hands-on experience performing a mock compliance audit.&nbsp; Participants gain knowledge in Quality Management Systems, explore aspects of the principles and responsibilities of a quality unit, understand the role quality assurance plays across functional areas and the importance of a [&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-3925","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/pages\/3925","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=3925"}],"version-history":[{"count":4,"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/pages\/3925\/revisions"}],"predecessor-version":[{"id":4568,"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/pages\/3925\/revisions\/4568"}],"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=3925"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}