{"id":46283,"date":"2022-07-18T19:01:45","date_gmt":"2022-07-18T17:01:45","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/statistical-elements-of-implementing-ich-guidelines-seminar-researchandmarkets-com\/"},"modified":"2022-07-18T19:01:45","modified_gmt":"2022-07-18T17:01:45","slug":"statistical-elements-of-implementing-ich-guidelines-seminar-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/statistical-elements-of-implementing-ich-guidelines-seminar-researchandmarkets-com\/","title":{"rendered":"Statistical Elements of Implementing ICH Guidelines Seminar &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5626166\/statistical-elements-of-implementing-ich?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=nl26s2&amp;utm_campaign=1727873+-+Statistical+Elements+of+Implementing+ICH+Guidelines+Seminar+&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;Statistical Elements of Implementing ICH Guidelines&#8221;<\/a> training has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220718005675\/en\/1516439\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220718005675\/en\/1516439\/21\/logo.jpg\"><\/a><\/p>\n<p>\nThis 2-day seminar explores the unique challenges facing quality functions of pharmaceutical and biotechnology companies.\n<\/p>\n<p>\nThis seminar will provide attendees with an understanding of the fourteen ICH Quality guidelines as relates to statistical guidance and analysis. The course will provide tools, techniques and insight that will allow participants to immediately begin implementation of the information learned within their organization\/firm.\n<\/p>\n<p>\nMost organizations have programs and procedures but they contain holes or fall short in the implementation of the tools and techniques used to apply proper statistical reasoning and analysis to ICH guidelines. Statistics can help you to better understand, implement, and track processes covered by the ICH guidelines?\n<\/p>\n<p>\nAttendees will learn practical implementation solutions as well as best practice descriptions that will allow management to effectively assess, manage and mitigate risk of poorly designed studies. Participants will learn statistical methods related to ICH guidelines and will discover how regulatory agencies, such as the FDA expect organizations to meet these guidelines.\n<\/p>\n<p>\n<strong>Learning objectives:<\/strong>\n<\/p>\n<ul>\n<li>\nCompare FDA requirements to ICH guidelines.\n<\/li>\n<li>\nPerform comparative analyses and regression analysis.\n<\/li>\n<li>\nKnow the difference between confidence and tolerance intervals.\n<\/li>\n<li>\nCalculate the appropriate sample size.\n<\/li>\n<li>\nCalculate the probability of risk.\n<\/li>\n<li>\nDefine and implement a process characterization strategy\n<\/li>\n<\/ul>\n<p>\n<strong>Who Should Attend:<\/strong>\n<\/p>\n<ul>\n<li>\nQuality Managers\n<\/li>\n<li>\nAssay Development Scientists\n<\/li>\n<li>\nQuality Analysts\n<\/li>\n<li>\nResearch Scientists\n<\/li>\n<li>\nRisk Managers\n<\/li>\n<\/ul>\n<p>\n<strong>Agenda<\/strong>\n<\/p>\n<p>\n<strong>Day 1:<\/strong>\n<\/p>\n<p>\n<strong>1. Review ICH Quality Guidelines (Q Series)<\/strong>\n<\/p>\n<ul>\n<li>\nQ1 Stability Testing\n<\/li>\n<li>\nQ2 Analytical Validation\n<\/li>\n<li>\nQ3A-3E Impurities\n<\/li>\n<li>\nQ4 Pharmacopoeias\n<\/li>\n<li>\nQ5A-5E Quality of Biotechnological Products\n<\/li>\n<li>\nQ6A-6B Specifications\n<\/li>\n<li>\nQ7 Good Manufacturing Practice\n<\/li>\n<li>\nQ8 Pharmaceutical Development\n<\/li>\n<li>\nQ9 Quality Risk Management\n<\/li>\n<li>\nQ10 Pharmaceutical Quality System\n<\/li>\n<li>\nQ11 Development and Manufacture of Drug Substances\n<\/li>\n<li>\nQ12 Lifecycle Management\n<\/li>\n<li>\nQ13 Continuous Manufacturing of Drug Substances and Drub Products\n<\/li>\n<li>\nQ14 Analytical Procedure Development\n<\/li>\n<\/ul>\n<p>\n<strong>2. Fundamentals of Statistics<\/strong>\n<\/p>\n<ul>\n<li>\nDescriptive and Summary Statistics\n<\/li>\n<li>\nGraphical Techniques\n<\/li>\n<li>\nNull Hypothesis Statistical Testing\n<\/li>\n<li>\nConfidence and Tolerance Intervals\n<\/li>\n<li>\nDiscussion\/Questions\n<\/li>\n<\/ul>\n<p>\n<strong>Day 2:<\/strong>\n<\/p>\n<p>\n<strong>1. Statistical Tests<\/strong>\n<\/p>\n<ul>\n<li>\nComparative Statistics\n<\/li>\n<li>\nt-tests, ANOVA\n<\/li>\n<li>\nNon-Parametric Tests\n<\/li>\n<li>\nRegression Analysis\n<\/li>\n<li>\nDetermine Sample Size (Power Analysis)\n<\/li>\n<\/ul>\n<p>\n<strong>2. Application to Industry<\/strong>\n<\/p>\n<ul>\n<li>\nDeveloping a Quality Risk Management Plan\n<\/li>\n<li>\nAssay Validation\n<\/li>\n<li>\nSetting Specifications\n<\/li>\n<li>\nPharmaceutical Development Quality System\n<\/li>\n<li>\nDiscussion\/Questions\n<\/li>\n<\/ul>\n<p>\nFor more information about this training visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5626166\/statistical-elements-of-implementing-ich?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=nl26s2&amp;utm_campaign=1727873+-+Statistical+Elements+of+Implementing+ICH+Guidelines+Seminar+&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/m3m8o7<\/a>.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nResearchAndMarkets.com<br \/>\n<br \/>Laura Wood, Senior Press Manager<br \/>\n<br \/><a target=\"_blank\" href=\"m&#97;&#105;&#x6c;&#x74;o&#58;&#112;&#x72;&#x65;&#x73;s&#64;&#114;&#x65;&#x73;ea&#114;&#x63;&#x68;&#x61;n&#100;&#109;&#x61;&#x72;ke&#116;&#x73;&#x2e;&#x63;o&#109;\" rel=\"nofollow noopener\" shape=\"rect\">pres&#115;&#64;&#114;&#101;&#115;&#101;&#97;&#x72;&#x63;&#x68;&#x61;&#x6e;&#x64;&#x6d;&#x61;&#x72;kets&#46;&#99;&#111;&#109;<\/a><\/p>\n<p>For E.S.T. Office Hours Call 1-917-300-0470<br \/>\n<br \/>For U.S.\/CAN Toll Free Call 1-800-526-8630<br \/>\n<br \/>For GMT Office Hours Call +353-1-416-8900\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Statistical Elements of Implementing ICH Guidelines&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. This 2-day seminar explores the unique challenges facing quality functions of pharmaceutical and biotechnology companies. This seminar will provide attendees with an understanding of the fourteen ICH Quality guidelines as relates to statistical guidance and analysis. The course will provide &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/statistical-elements-of-implementing-ich-guidelines-seminar-researchandmarkets-com\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":["entry","post","publish","author-business","post-46283","format-standard","category-industry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Statistical Elements of Implementing ICH Guidelines Seminar - ResearchAndMarkets.com - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/statistical-elements-of-implementing-ich-guidelines-seminar-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Statistical Elements of Implementing ICH Guidelines Seminar - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Statistical Elements of Implementing ICH Guidelines&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. 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