{"id":3419,"date":"2024-06-04T18:40:22","date_gmt":"2024-06-04T18:40:22","guid":{"rendered":"https:\/\/www.gilero.com\/uncategorized\/cgmp-expectations-for-drug-led-versus-device-led-combination-products-webinar\/"},"modified":"2026-09-01T18:31:25","modified_gmt":"2026-09-01T18:31:25","slug":"cgmp-expectations-for-drug-led-versus-device-led-combination-products-webinar","status":"publish","type":"blog","link":"https:\/\/www.sanner-group.com\/insights\/blog\/cgmp-expectations-for-drug-led-versus-device-led-combination-products-webinar\/","title":{"rendered":"cGMP Expectations for Drug-led Versus Device-led Combination Products Webinar"},"content":{"rendered":"\n<section id=\"armstrong-block-editor-block_c2f5cc8a6e02789875c99a60f3bb1be1\" class=\"armstrong-block armstrong-block-editor\" >\n    <div class=\"container-fluid\">\n        <div class=\"row\">\n            <div class=\"col-lg-12\">\n                                <p><!-- wp:html --><\/p>\n<div style=\"padding: 56.25% 0 0 0; position: relative;\"><iframe style=\"position: absolute; top: 0; left: 0; width: 100%; height: 100%;\" title=\"cGMP Expectations for Drug-led versus Device-led Combination Products\" src=\"https:\/\/player.vimeo.com\/video\/951662672?badge=0&amp;autopause=0&amp;player_id=0&amp;app_id=58479\" frameborder=\"0\"><\/iframe><\/div>\n<p><script src=https:\/\/player.vimeo.com\/api\/player.js><\/script><\/p>\n<p><!-- \/wp:html --><\/p>\n<p><!-- wp:spacer {\"height\":\"50px\"} --><\/p>\n<div class=\"wp-block-spacer\" style=\"height: 50px;\" aria-hidden=\"true\"><\/div>\n<p><!-- \/wp:spacer --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Speakers on this webinar discuss the combination product cGMP operating system requirements that support development, manufacturing, premarket regulatory evaluation, and commercialization of combination products.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Combination products are therapeutic or diagnostic medical products that combine drugs, devices, and\/or biological products with one another. The FDA regulation of combination products, 21 CFR Part 4, became effective 22 July 2013. Final guidance on cGMPs for combination products was issued in January 2017, and a list of alternative or streamlined mechanisms for compliance with cGMPs for combination products was later issued in September 2022.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Speakers Include:<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:list --><\/p>\n<ul class=\"wp-block-list\">\n<li style=\"list-style-type: none;\">\n<ul class=\"wp-block-list\"><!-- wp:list-item --><\/p>\n<li><strong>Susan Neadle<\/strong>, MS, BS, FRAPS, FAAO, President, <a href=\"https:\/\/www.combinationproductsconsulting.com\/\">Combination Products Consulting Services LLC<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><!-- \/wp:list-item --><\/p>\n<p><!-- wp:list-item --><\/p>\n<ul class=\"wp-block-list\">\n<li style=\"list-style-type: none;\">\n<ul class=\"wp-block-list\">\n<li><strong>Hope Tuck<\/strong>, VP, Quality &amp; Compliance, Sanner America<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><!-- \/wp:list-item --><\/p>\n<p><!-- wp:list-item --><\/p>\n<ul class=\"wp-block-list\">\n<li style=\"list-style-type: none;\">\n<ul class=\"wp-block-list\">\n<li><strong>Jim Fentress<\/strong>, Director of Regulatory Affairs, Gilero<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><!-- \/wp:list-item --><\/p>\n<p><!-- \/wp:list --><\/p>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"featured_media":0,"template":"","blog_category":[],"class_list":["post-3419","blog","type-blog","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>cGMP Expectations for Drug- vs Device-led Combination Products<\/title>\n<meta name=\"description\" content=\"Webinar on cGMP expectations for drug-led versus device-led combination products clarifies compliance strategies for developers and manufacturers alike.\" \/>\n<meta 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