{"id":431,"date":"2022-09-08T19:49:46","date_gmt":"2022-09-08T18:49:46","guid":{"rendered":"https:\/\/www.ceutiqus.com\/bam\/?p=431"},"modified":"2022-09-15T06:56:55","modified_gmt":"2022-09-15T05:56:55","slug":"how-to-intelligently-optimise-and-integrate-quality-qbd-qrm-qms-into-advanced-therapy-medicinal-products-atmps","status":"publish","type":"post","link":"https:\/\/www.ceutiqus.com\/bam\/how-to-intelligently-optimise-and-integrate-quality-qbd-qrm-qms-into-advanced-therapy-medicinal-products-atmps\/","title":{"rendered":"How to Intelligently Optimise and Integrate Quality (QbD, QRM, QMS) into Advanced Therapy Medicinal Products (ATMPs)"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">I spoke on this subject at the Stem Cell &amp; Regenerative Medicine Congress, Berlin, in September 2017, but let me summarise it in ONE minute (starting now)&#8230;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">IQ= QbD x QMS x QRM<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Quality by Design (QbD)<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A common question I get asked is &#8220;ATMPs are so complex that we can&#8217;t really use the QbD approach can we?&#8221;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">My typical answer to this is: &#8220;the greater the complexity the more we MUST use QbD for necessary understanding!&#8221;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">We have to delineate what really matters from what doesn&#8217;t to be able to make accurate science-to-patient-linked impact assessments.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Integrate understanding your product AND your patient; this requires excellence in both science and medicine, whether we&#8217;re considering CAR-T cells in oncology or cell and gene therapies for treating optic neuropathies such as glaucoma.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Quality Management Systems (QMS)<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Great systems are to successful companies what great habits are to successful people.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">They COMPOUND over time. So discipline yourself to continuously raise your standards and optimise before you automate.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Do this habitually and let the results compound in the right direction.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Quality Risk Management (QRM)<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Get world-class at solving problems&#8230;then get&nbsp;<em>even better<\/em>&nbsp;at PREEMPTING and preventing them.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">&#8220;A clever person solves a problem, a wise person avoids it.&#8221; Albert Einstein.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Integrated Quality (IQ)<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Getting cutting edge at these simple basics (with practice, practice, practice) leads to inevitable excellence and quality.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">My simple rule and acronym to help you remember these in your daily practice is to &#8220;always reference your work (REFS).&#8221;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">That is, make it:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>R<\/strong>isk-based<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>E<\/strong>vidence-based<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>F<\/strong>act-based<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>S<\/strong>cience-based\/<strong>S<\/strong>ystem-based<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Get your FREE downloadable &#8220;20 Insights into BioPharmaceutiQals&#8221; at:<\/p>\n\n\n\n<figure class=\"wp-block-embed\"><div class=\"wp-block-embed__wrapper\">\nhttps:\/\/biopharmaceutiqalsacademy.mykajabi.com\/20-insights\n<\/div><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">CeutiQus. Dr Jasbir Rattu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Innovating Quality Medicines Intelligently.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">#ATMP #regenerativemedicine #celltherapy #genetherapy #tissueengineering #biotechnology #Innovation #quality #Intelligence #medicine #success #inspiration<\/p>\n","protected":false},"excerpt":{"rendered":"<p>I spoke on this subject at the Stem Cell &amp; Regenerative Medicine Congress, Berlin, in September 2017, but let me summarise it in ONE minute (starting now)&#8230; IQ= QbD x QMS x QRM Quality by Design (QbD) A common question I get asked is &#8220;ATMPs are so complex that we can&#8217;t really use the QbD [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"off","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-431","post","type-post","status-publish","format-standard","hentry","category-uncategorised"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>How to Intelligently Optimise and Integrate Quality (QbD, QRM, QMS) into Advanced Therapy Medicinal Products (ATMPs) - CeutiQus &amp; BAM<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.ceutiqus.com\/bam\/how-to-intelligently-optimise-and-integrate-quality-qbd-qrm-qms-into-advanced-therapy-medicinal-products-atmps\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How to Intelligently Optimise and Integrate Quality (QbD, QRM, QMS) into Advanced Therapy Medicinal Products (ATMPs) - CeutiQus &amp; BAM\" \/>\n<meta property=\"og:description\" content=\"I spoke on this subject at the Stem Cell &amp; Regenerative Medicine Congress, Berlin, in September 2017, but let me summarise it in ONE minute (starting now)&#8230; IQ= QbD x QMS x QRM Quality by Design (QbD) A common question I get asked is &#8220;ATMPs are so complex that we can&#8217;t really use the QbD [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.ceutiqus.com\/bam\/how-to-intelligently-optimise-and-integrate-quality-qbd-qrm-qms-into-advanced-therapy-medicinal-products-atmps\/\" \/>\n<meta property=\"og:site_name\" content=\"CeutiQus &amp; 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