{"id":4934,"date":"2019-01-09T10:17:37","date_gmt":"2019-01-09T09:17:37","guid":{"rendered":"https:\/\/stage.dataductus.com\/?post_type=tribe_events&#038;p=4934"},"modified":"2021-07-16T09:47:22","modified_gmt":"2021-07-16T08:47:22","slug":"workshop-data-integrity","status":"publish","type":"events","link":"https:\/\/ductus.global\/sv\/events\/workshop-data-integrity\/","title":{"rendered":"Seminar on Data integrity &#038; Practical FDA Title 21 CFR Part 11"},"content":{"rendered":"\n\n\n <section class=\"hero-banner top-banner left has-ductus-blue-background-color ductus-banner-block alignfull banner-module\" style=\"min-height: 300px\">\n    <div id=\"top-banner-block_60f146d933ca0\"  class=\"banner-content\">\n        <figure id=\"banner-image-block_60f146d933ca0\" class=\"banner-image\" role=img data-title=title-not-available  style=\"background-image:url(https:\/\/ductus.global\/wp-content\/uploads\/2019\/01\/Data-Ductus-Life-Science-Event.jpg);  background-position: 50% 50%\"\"><\/figure>\n        <div class=\"inner has-ductus-blue-background-color has-white-color has-text-color\">\n\t\t\t\t\t\t    <span class=\"preheader\">SEMINAR<\/span>\n            \n\t\t\t\t\t\t\t<h1 class=\"h1 banner-title\"> Data integrity &#038; Practical FDA Title 21 CFR Part 11<\/h1>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n<\/section>\n\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p class=\"has-preamble-font-size\"><span style=\"font-size: 14pt;\">Data Ductus offers a seminar, free of charge, in Uppsala on the 26<sup>th<\/sup> of February. The seminar will be held in Swedish unless there are English speaking participants.<\/span><\/p>\n\n\n\n<p><span style=\"font-size: 14pt;\">The pharmaceutical and medical device industry is experiencing a digital transformation driven by the need to enable efficient data sharing and automation in its manufacturing and distribution practices &#8211; typically by means of GxP systems. Ensuring regulatory compliance in this transformation is often challenging. There are practical, procedural as well as technical aspects to consider.<\/span><\/p>\n\n\n\n<p><span style=\"font-size: 14pt;\">Our seminar begins with a crash course on the impact that especially Title 21 CFR Part 11 of the US Code of Federal regulations has on the industry, its requirements on data integrity and corresponding procedural and technical implications. We highlight some common difficulties and discuss best practices for dealing with them.<\/span><\/p>\n\n\n\n<p><strong>Event registration:<\/strong> This event has passed.<\/p>\n\n\n\n<p><strong>Agenda:<br><\/strong>15.00-15.15 &#8211; Introduction<br>15.15-16.15 \u2013 Title 21 CFR Part 11 presentation and analysis of its impact<br>16.15-16.30 \u2013 Coffee break<br>16.30-16.45 \u2013 Introducing focus areas for drill-down discussions<br>17.00-18.00 \u2013 Seminar discussions on specific themes<\/p>\n\n\n\n<p>At least two of the following themes (depending on participants&#8217; interests) will be discussed in more detail during group discussions:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>When does ER\/ES (part 11) apply?<\/li><li>System Validation &#8211; 11.10(a) (Limited and authorized system access)<\/li><li>User-Independent Computer-Generated Time-Stamped Audit Trails &#8211; 11.10(e)<\/li><li>Accurate and Complete Copies \u00a711.10(c)<\/li><li>Record and Signature linking &#8211; \u00a711.70<\/li><\/ul>\n\n\n\n<p>For further questions please email eventsmanager (at) dataductus.se.<\/p>\n\n\n\n<p>Welcome!<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n    <section id=\"event-main-info-block_60f1474433ca1\" class=\"event-main-info-block\" itemscope itemtype=\"https:\/\/schema.org\/Event\">\n        <div class=\"inner\">\n\n\t        \n        <div class=\"event-meta\">\n\n         \t\n            <div class=\"event-description meta-section\">\n                <h5 class=\"section-header meta-section\">N\u00e4r<\/h5>\n                                    <span class=\"info past-event\">Februari 26 2019, 15:00 \u2013 18:00 (UTC+01:00)<\/span>\n                        <\/div>\n            \n                        <div class=\"event-venue meta-section\">\n                <h5 class=\"section-header\">Plats<\/h5>\n                <div class=\"address\" itemprop=\"location\" itemscope itemtype=\"https:\/\/schema.org\/Place\">\n                                            <span class=\"venue_name\" itemprop=\"name\">Data Ductus<\/span>\n                                        <div class=\"venue_address\" itemprop=\"address\" itemscope itemtype=\"https:\/\/schema.org\/PostalAddress\">\n                                            <span class=\"venue_streetAddress\" itemprop=\"streetAddress\">Smedsgr\u00e4nd 3<\/span>\n                    \t\t            \t\t\t        \t\t\t\t                            <span class=\"venue_postalCode\" itemprop=\"postalCode\">75320<\/span>\n\t\t            \t                                                <span class=\"venue_city\" itemprop=\"postalCode\">Uppsala<\/span>\n\t                    \t\t\t\t\t                        <span class=\"venue_addressCountry\" itemprop=\"addressCountry\">Sweden<\/span>\n\t\t\t\t\t                                                  <a class=\"text-link\" href=\"https:\/\/www.google.com\/maps\/search\/?api=1&#038;query=Data+Ductus%2C+Smedsgr%C3%A4nd+3%2C+75320%2C+Sweden\" target=\"_blank\">Visa karta<\/a>\n                                            <\/div>\n                                    <\/div>\n            <\/div>\n            \t        \n\n\t                <\/div>\n\n\n        <\/div>\n    <\/section>\n\t<\/div>\n<\/div>\n\n\n\n<div style=\"height:150px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Data Ductus offers a seminar, free of charge, in Uppsala on the 26th of February. The seminar will be held in Swedish unless there are English speaking participants. The pharmaceutical and medical device industry is experiencing a digital transformation driven by the need to enable efficient data sharing and automation in its manufacturing and distribution [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":5002,"parent":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"categories":[4168],"tags":[],"class_list":["post-4934","events","type-events","status-publish","has-post-thumbnail","hentry","category-seminar"],"acf":[],"_links":{"self":[{"href":"https:\/\/ductus.global\/sv\/wp-json\/wp\/v2\/events\/4934","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ductus.global\/sv\/wp-json\/wp\/v2\/events"}],"about":[{"href":"https:\/\/ductus.global\/sv\/wp-json\/wp\/v2\/types\/events"}],"author":[{"embeddable":true,"href":"https:\/\/ductus.global\/sv\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/ductus.global\/sv\/wp-json\/wp\/v2\/comments?post=4934"}],"version-history":[{"count":0,"href":"https:\/\/ductus.global\/sv\/wp-json\/wp\/v2\/events\/4934\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ductus.global\/sv\/wp-json\/wp\/v2\/media\/5002"}],"wp:attachment":[{"href":"https:\/\/ductus.global\/sv\/wp-json\/wp\/v2\/media?parent=4934"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ductus.global\/sv\/wp-json\/wp\/v2\/categories?post=4934"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ductus.global\/sv\/wp-json\/wp\/v2\/tags?post=4934"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}