{"id":661,"date":"2019-10-05T23:04:54","date_gmt":"2019-10-05T21:04:54","guid":{"rendered":"https:\/\/borgensgaard-consulting.dk\/?page_id=661"},"modified":"2020-06-18T08:27:25","modified_gmt":"2020-06-18T06:27:25","slug":"regulativer-og-standarder","status":"publish","type":"page","link":"https:\/\/borgensgaard-consulting.dk\/da\/services\/regulativer-og-standarder\/","title":{"rendered":"Regulatory Compliance"},"content":{"rendered":"<div id=\"pl-661\"  class=\"panel-layout\" ><div id=\"pg-661-0\"  class=\"panel-grid panel-no-style\" ><div id=\"pgc-661-0-0\"  class=\"panel-grid-cell\" ><div id=\"panel-661-0-0-0\" class=\"so-panel widget widget_sow-image panel-first-child panel-last-child\" data-index=\"0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-image so-widget-sow-image-default-dbf295114b96-661\"\n\t\t\t\n\t\t>\n\n<div class=\"sow-image-container\">\n\t\t<img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/borgensgaard-consulting.dk\/wp-content\/uploads\/2019\/10\/regulativer-og-standarder.jpg\" width=\"1105\" height=\"468\" srcset=\"https:\/\/borgensgaard-consulting.dk\/wp-content\/uploads\/2019\/10\/regulativer-og-standarder.jpg 1105w, https:\/\/borgensgaard-consulting.dk\/wp-content\/uploads\/2019\/10\/regulativer-og-standarder-300x127.jpg 300w, https:\/\/borgensgaard-consulting.dk\/wp-content\/uploads\/2019\/10\/regulativer-og-standarder-768x325.jpg 768w, https:\/\/borgensgaard-consulting.dk\/wp-content\/uploads\/2019\/10\/regulativer-og-standarder-1024x434.jpg 1024w\" sizes=\"(max-width: 1105px) 100vw, 1105px\" title=\"regulativer og standarder\" alt=\"Regulativer og Standarder\" \t\tclass=\"so-widget-image\"\/>\n\t<\/div>\n\n<\/div><\/div><\/div><\/div><div id=\"pg-661-1\"  class=\"panel-grid panel-no-style\" ><div id=\"pgc-661-1-0\"  class=\"panel-grid-cell\" ><div id=\"panel-661-1-0-0\" class=\"so-panel widget widget_sow-editor panel-first-child panel-last-child\" data-index=\"1\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-editor so-widget-sow-editor-base\"\n\t\t\t\n\t\t>\n<div class=\"siteorigin-widget-tinymce textwidget\">\n\t<h2>Regulatory Compliance\u00a0<!-- wp:paragraph --><\/h2>\n<p>Jeg har igennem en lang karriere i life science industrien, som ansvarlig for kvalitet og regulatoriske forhold, arbejdet med mange forskellige regulativer og standarder herunder<\/p>\n<ul>\n<li><a href=\"https:\/\/borgensgaard-consulting.dk\/da\/medical-device-regulation-mdr\/\">Medical Device Directive &amp; Regulation<\/a><\/li>\n<li>FDA (US Food &amp; Drug Administration Requirements) \u2013 herunder part 820 Quality System Regulation<\/li>\n<li>US Pharmacopeia \u2013 fokus p\u00e5 prim\u00e6r plastemballage<\/li>\n<li>European Pharmacopeia - fokus p\u00e5 prim\u00e6r plastemballage<\/li>\n<li>European Food Law \u2013 fokus p\u00e5 plastemballage<\/li>\n<li>REACH<\/li>\n<li>cGMP \u2013 Current Good Manufacturing Practice<\/li>\n<li>ISO 9001 - Quality Management<\/li>\n<li>ISO 15378 - Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)<\/li>\n<li>ISO 13485 - Medical devices -- Quality management systems -- Requirements for regulatory purposes<\/li>\n<li>ISO 31000 - Risk Management<\/li>\n<li>ISO 14644 - Cleanrooms and associated controlled environments<\/li>\n<li>ISO 14698 - Cleanrooms and associated controlled environments \u2013 Biocontamination control<\/li>\n<li>ISO 8573 - Compressed Air<\/li>\n<li>ISO 2859 - Sampling procedures for inspection by attributes \u2014 Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection<\/li>\n<li>GAMP 5 - Good Automated Manufacturing Practice<\/li>\n<\/ul>\n<p>Da jeg ikke har listet alle de standarder, som jeg har arbejdet med, er du meget velkommen til at kontakte mig for yderligere information, hvis dine behov ikke umiddelbart er d\u00e6kket af ovenst\u00e5ende.<\/p>\n<p>&nbsp;<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:image {\"id\":248,\"align\":\"right\",\"width\":338,\"height\":339} --><\/p>\n<div class=\"wp-block-image\"><\/div>\n<p><!-- \/wp:paragraph --><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>Regulatory Compliance\u00a0 Jeg har igennem en lang karriere i life science industrien, som ansvarlig for kvalitet og regulatoriske forhold, arbejdet [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":613,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"class_list":["post-661","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.3 - 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