{"id":53371,"date":"2023-01-27T14:02:16","date_gmt":"2023-01-27T13:02:16","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/cgmp-regulatory-inspections-through-the-eyes-of-fda-ema-and-pmda-march-7-2023-researchandmarkets-com\/"},"modified":"2023-01-27T14:02:16","modified_gmt":"2023-01-27T13:02:16","slug":"cgmp-regulatory-inspections-through-the-eyes-of-fda-ema-and-pmda-march-7-2023-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/cgmp-regulatory-inspections-through-the-eyes-of-fda-ema-and-pmda-march-7-2023-researchandmarkets-com\/","title":{"rendered":"cGMP Regulatory Inspections &#8211; Through the Eyes of FDA, EMA and PMDA (March 7, 2023) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5724275\/cgmp-regulatory-inspections-through-the-eyes-of?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=rm3br5&amp;utm_campaign=1813925+-+cGMP+Regulatory+Inspections+-+Through+the+Eyes+of+FDA%2C+EMA+and+PMDA+(March+7%2C+2023)&amp;utm_exec=como322prd-regulatory?w=4\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;cGMP Regulatory Inspections &#8211; Through the Eyes of FDA, EMA and PMDA&#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\/20230127005190\/en\/1698080\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230127005190\/en\/1698080\/21\/logo.jpg\"><\/a><\/p>\n<p>\nGMP-compliance is a must for manufacturers of finished pharmaceutical products and active pharmaceutical ingredients (APIs) according to the different national legislations. The related GMP rules are typically valid for one country based upon the anchoring in the respective national laws. However, at the same time the GMP rules are more or less internationally harmonized such as e.g. the ICH Q7 Guidelines representing the &#8220;Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients&#8221; being adopted by the regulatory bodies of the European Union (EU), Japan and USA.\n<\/p>\n<p>\n<strong>Why Should You Attend<\/strong>\n<\/p>\n<p>\nIt has often been stated that &#8220;FDA inspects for compliance; European inspectors inspect for adequate science&#8221;. Yet GMPs have been enshrined into law for many countries and a drug\/biologic\/medical device manufacturer should have a reasonable expectation of all inspections being the same.\n<\/p>\n<p>\nICH Q7 was established by US \/ EU and Japan to harmonize inspections in their respective countries. This webinar will cover the key areas of how ICH Q7 was established, it&#8217;s goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.. After this event, you will be fully prepared for cGMP regulatory inspections in those countries.\n<\/p>\n<p>\n<strong>Who Should Attend:<\/strong>\n<\/p>\n<ul>\n<li>\nManufacturing\n<\/li>\n<li>\nQuality Control\n<\/li>\n<li>\nQuality Assurance\n<\/li>\n<li>\nSenior Management\n<\/li>\n<li>\nProject Managers\n<\/li>\n<li>\nQualified Persons (QPs)\n<\/li>\n<li>\nRegulatory Compliance\n<\/li>\n<li>\nCMC Personnel\n<\/li>\n<li>\nPackaging Experts\n<\/li>\n<li>\nAuditors and Staff\n<\/li>\n<li>\nIT Subject Matter Experts\u00a0\n<\/li>\n<\/ul>\n<p>\n<strong>Key Topics Covered:<\/strong>\n<\/p>\n<p>\n<strong>Session 1:<\/strong>\n<\/p>\n<p>\n<strong>U.S., EU, and Japan GMPs &#8211; Status of Harmonization&amp; Future Trends<\/strong>\n<\/p>\n<ul>\n<li>\nCurrent status of harmonization of GMP requirements\n<\/li>\n<li>\nFuture Trends\n<\/li>\n<\/ul>\n<p>\n<strong>Where Inconsistencies Become a Problem: WHO, ICH, Countries<\/strong>\n<\/p>\n<ul>\n<li>\nDiscrepancies in global expectations\n<\/li>\n<li>\nAlignment issues\n<\/li>\n<\/ul>\n<p>\n<strong>Key Chapter Reviews<\/strong>\n<\/p>\n<ul>\n<li>\nICH GMP organization\n<\/li>\n<li>\nCategory reviews\n<\/li>\n<\/ul>\n<p>\n<strong>Compliance with ICH Guidelines for GMPs<\/strong>\n<\/p>\n<ul>\n<li>\nUnderstanding and Insight into Healthcare Authority expectations\n<\/li>\n<li>\nHow GMP requirements\/inspections can differ with a single ICH Standard\n<\/li>\n<li>\nHow regulators (from 3 regions) will assess\/enforce compliance with Q7\n<\/li>\n<\/ul>\n<p>\n<strong>Session 2:<\/strong>\n<\/p>\n<p>\n<strong>APIs<\/strong>\n<\/p>\n<ul>\n<li>\nAuditing API facilities\n<\/li>\n<li>\nTypical audit agenda\n<\/li>\n<li>\nICH Area differences\n<\/li>\n<\/ul>\n<p>\n<strong>Finished Products<\/strong>\n<\/p>\n<ul>\n<li>\nAuditing finished product facilities\n<\/li>\n<li>\nTypical audit agenda\n<\/li>\n<li>\nICH Area differences\n<\/li>\n<\/ul>\n<p>\n<strong>Excipients<\/strong>\n<\/p>\n<p>\n<strong>Sterile products<\/strong>\n<\/p>\n<p>\n<strong>Biologics<\/strong>\n<\/p>\n<p>\n<strong>Clinical Packaging<\/strong>\n<\/p>\n<p>\n<strong>Session 3:<\/strong>\n<\/p>\n<p>\n<strong>Area GMP Inspections<\/strong>\n<\/p>\n<ul>\n<li>\nDifferences on how GMP inspections are conducted\n<\/li>\n<li>\nAreas of GMP inspection focus by area\n<\/li>\n<li>\nModifying your self-inspection systems to customized area concerns\n<\/li>\n<\/ul>\n<p>\n<strong>Outsourcing Management Regional Perspective on:<\/strong>\n<\/p>\n<ul>\n<li>\nContract manufacturing\n<\/li>\n<li>\nContract packaging.\n<\/li>\n<li>\n3rd Party Contract testing\n<\/li>\n<\/ul>\n<p>\n<strong>Auditing Your Facilities for Global Considerations<\/strong>\n<\/p>\n<ul>\n<li>\nImportance of pre-audits to regional GMP focus.\n<\/li>\n<li>\nHow to focus your internal audits to a US, EU and Japan compliance system.\n<\/li>\n<\/ul>\n<p>\n<strong>Speakers:<\/strong>\n<\/p>\n<p>\nKelly Thomas\n<\/p>\n<p>\nVice President\n<\/p>\n<p>\nStallergenes Greer\n<\/p>\n<p>\nMs. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process\/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment\/automated processes and cleaning validation.\n<\/p>\n<p>\nUtilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.\n<\/p>\n<p>\nFor more information about this training visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5724275\/cgmp-regulatory-inspections-through-the-eyes-of?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=rm3br5&amp;utm_campaign=1813925+-+cGMP+Regulatory+Inspections+-+Through+the+Eyes+of+FDA%2C+EMA+and+PMDA+(March+7%2C+2023)&amp;utm_exec=como322prd-regulatory?w=4\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/cmp3qn-regulatory?w=4<\/a>\n<\/p>\n<p>\n<strong>About ResearchAndMarkets.com<\/strong>\n<\/p>\n<p>\nResearchAndMarkets.com is the world&#8217;s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.\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=\"&#109;&#x61;i&#108;&#x74;o&#58;&#x70;r&#101;&#x73;s&#64;&#x72;&#101;&#x73;&#x65;&#97;&#x72;&#x63;&#104;&#x61;n&#100;&#x6d;a&#114;&#x6b;e&#116;&#x73;&#46;&#99;&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#x70;&#114;&#x65;&#x73;&#115;&#x40;&#x72;&#101;&#x73;&#x65;&#97;&#x72;&#x63;h&#x61;&#x6e;d&#x6d;&#97;r&#x6b;&#101;t&#x73;&#46;c&#x6f;&#109;<\/a><br \/>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;cGMP Regulatory Inspections &#8211; Through the Eyes of FDA, EMA and PMDA&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. GMP-compliance is a must for manufacturers of finished pharmaceutical products and active pharmaceutical ingredients (APIs) according to the different national legislations. The related GMP rules are typically valid for one country based upon the &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/cgmp-regulatory-inspections-through-the-eyes-of-fda-ema-and-pmda-march-7-2023-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-53371","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>cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA (March 7, 2023) - 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\/cgmp-regulatory-inspections-through-the-eyes-of-fda-ema-and-pmda-march-7-2023-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA (March 7, 2023) - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;cGMP Regulatory Inspections &#8211; Through the Eyes of FDA, EMA and PMDA&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. 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