{"id":45016,"date":"2022-06-13T18:01:43","date_gmt":"2022-06-13T16:01:43","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/2-day-virtual-fda-and-eu-process-validation-and-equipment-qualification-training-course-october-20-21-2022-researchandmarkets-com\/"},"modified":"2022-06-13T18:01:43","modified_gmt":"2022-06-13T16:01:43","slug":"2-day-virtual-fda-and-eu-process-validation-and-equipment-qualification-training-course-october-20-21-2022-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/2-day-virtual-fda-and-eu-process-validation-and-equipment-qualification-training-course-october-20-21-2022-researchandmarkets-com\/","title":{"rendered":"2 Day Virtual FDA and EU Process Validation and Equipment Qualification Training Course, October 20-21, 2022 &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5595751\/fda-and-eu-process-validation-and-equipment?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=mwgwp8&amp;utm_campaign=1712897+-+2+Day+Virtual+FDA+and+EU+Process+Validation+and+Equipment+Qualification+Training+Course%2C+October+20-21%2C+2022&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;FDA and EU Process Validation and Equipment Qualification Training Course&#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\/20220613005662\/en\/1484678\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220613005662\/en\/1484678\/21\/logo.jpg\"><\/a><\/p>\n<p>\nThe FDA&#8217;s Quality System Regulation (QSR) is clear on the importance of equipment controls &#8211; you must have and follow procedures for installing, operating and maintaining all equipment used in your manufacturing processes. And that includes any ancillary equipment that affects production, such as environmental systems and contamination controls.\n<\/p>\n<p>\nThis training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP). The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.\n<\/p>\n<p>\n<strong>Why Should you Attend:<\/strong>\n<\/p>\n<p>\n<strong>Participants will gain:<\/strong>\n<\/p>\n<ul>\n<li>\nAn understanding of what the global expectations are for equipment qualification and validation\n<\/li>\n<li>\nAn understanding of the documents required for equipment qualification and process validation and how to manage documents appropriately\n<\/li>\n<li>\nUnderstand and know how to write and maintain a Validation Master Plan\n<\/li>\n<li>\nBetter writing and execution skills for sound protocols for equipment qualification (IQ, OQ, PQ) and process validation\n<\/li>\n<li>\nAbility to qualify already existing systems more effectively and efficiently and to execute requalification&#8217;s more effectively\n<\/li>\n<li>\nAbility to collect data, conduct tests, and obtain all necessary documents\n<\/li>\n<li>\nAn understanding of the different types of validation\n<\/li>\n<li>\nAn understanding of performance validation\n<\/li>\n<li>\nKnowledge of the guidelines on validating analytical methods and processes\n<\/li>\n<li>\nAbility to support equipment qualification and validation through the quality management system, risk analysis, calibration and maintenance, and change control\n<\/li>\n<li>\nAn understanding and knowledge of the principles of auditing the equipment qualification and validation\n<\/li>\n<li>\nAn understanding of external qualifications and validations from a contract manufacturer, and qualifications and validations by a supplier\n<\/li>\n<li>\nAbility to investigate true root causes of problems and to evaluate and prioritize solutions\n<\/li>\n<li>\nAbility to develop effective problem solving methods to help you assess which is best for your situation\n<\/li>\n<li>\nAbility to develop successful implementation plans\n<\/li>\n<li>\nAbility to perform risk assessments effectively\n<\/li>\n<\/ul>\n<p>\n<strong>Key Topics Covered:<\/strong>\n<\/p>\n<p>\n<strong>DAY 1<\/strong>\n<\/p>\n<p>\n<strong>Regulatory Requirements and Expectations for Equipment Qualification<\/strong>\n<\/p>\n<ul>\n<li>\nEurope\n<\/li>\n<li>\nFDA\n<\/li>\n<li>\nGlobal harmonization and expectations\n<\/li>\n<li>\nManagement of Documents, Documents Required\n<\/li>\n<\/ul>\n<p>\n<strong>Validation policy<\/strong>\n<\/p>\n<ul>\n<li>\nValidation Master Plan (VMP)\n<\/li>\n<li>\nDocuments equipment qualification\n<\/li>\n<li>\nSOPs\n<\/li>\n<li>\nResponsibilities\n<\/li>\n<li>\nValidation team\n<\/li>\n<\/ul>\n<p>\n<strong>General Aspects of Qualification<\/strong>\n<\/p>\n<p>\n<strong>Qualification phases, DQ, IQ, OQ, PQ<\/strong>\n<\/p>\n<ul>\n<li>\nDesign Qualification\n<\/li>\n<li>\nInstallation Qualification\n<\/li>\n<li>\nOperational Qualification\n<\/li>\n<li>\nProcess Qualification\n<\/li>\n<li>\nPerformance Qualification\n<\/li>\n<\/ul>\n<p>\n<strong>Questions \/ Comments \/ Discussion<\/strong>\n<\/p>\n<p>\n<strong>DAY 2<\/strong>\n<\/p>\n<p>\n<strong>Operational Qualification of existing systems and equipment<\/strong>\n<\/p>\n<ul>\n<li>\nRequalification\/validation\n<\/li>\n<\/ul>\n<p>\n<strong>Performance Qualification and Process Validation<\/strong>\n<\/p>\n<p>\n<strong>Writing SOPs<\/strong>\n<\/p>\n<ul>\n<li>\nWriting a qualification protocol, content\n<\/li>\n<\/ul>\n<p>\n<strong>Executing a qualification<\/strong>\n<\/p>\n<p>\n<strong>Tests and data<\/strong>\n<\/p>\n<p>\n<strong>Documents and writing a qualification report<\/strong>\n<\/p>\n<p>\n<strong>Final Questions \/ Comments \/ Discussion<\/strong>\n<\/p>\n<p>\nFor more information about this training visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5595751\/fda-and-eu-process-validation-and-equipment?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=mwgwp8&amp;utm_campaign=1712897+-+2+Day+Virtual+FDA+and+EU+Process+Validation+and+Equipment+Qualification+Training+Course%2C+October+20-21%2C+2022&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/w97y5h<\/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=\"&#109;&#97;&#x69;&#x6c;&#116;&#111;&#x3a;&#x70;&#114;&#101;&#x73;&#x73;&#64;&#114;&#x65;&#x73;&#101;&#97;&#x72;&#x63;&#104;&#97;&#x6e;&#x64;&#109;&#97;&#x72;&#x6b;&#101;&#116;&#x73;&#x2e;&#99;&#111;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">pr&#101;&#115;&#x73;&#x40;&#x72;&#x65;se&#97;&#114;&#x63;&#x68;&#x61;&#x6e;dm&#97;&#114;&#107;&#x65;&#x74;&#x73;&#x2e;co&#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;FDA and EU Process Validation and Equipment Qualification Training Course&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. The FDA&#8217;s Quality System Regulation (QSR) is clear on the importance of equipment controls &#8211; you must have and follow procedures for installing, operating and maintaining all equipment used in your manufacturing processes. And that includes &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/2-day-virtual-fda-and-eu-process-validation-and-equipment-qualification-training-course-october-20-21-2022-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-45016","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>2 Day Virtual FDA and EU Process Validation and Equipment Qualification Training Course, October 20-21, 2022 - 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\/2-day-virtual-fda-and-eu-process-validation-and-equipment-qualification-training-course-october-20-21-2022-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"2 Day Virtual FDA and EU Process Validation and Equipment Qualification Training Course, October 20-21, 2022 - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;FDA and EU Process Validation and Equipment Qualification Training Course&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. 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