{"id":567,"date":"2018-07-23T09:50:02","date_gmt":"2018-07-23T14:50:02","guid":{"rendered":"http:\/\/variation.com\/?page_id=567"},"modified":"2021-05-30T21:52:05","modified_gmt":"2021-05-31T02:52:05","slug":"process-validation-principles","status":"publish","type":"page","link":"https:\/\/variation.com\/courses\/process-validation-principles\/","title":{"rendered":"Process Validation Principles"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"567\" class=\"elementor elementor-567\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-b0eb324 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b0eb324\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8b78595\" data-id=\"8b78595\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f41cef9 elementor-widget elementor-widget-global elementor-global-1759 elementor-widget-breadcrumbs\" data-id=\"f41cef9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"breadcrumbs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p id=\"breadcrumbs\"><span><span><a href=\"https:\/\/variation.com\/\">Home<\/a><\/span><\/span><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d14fb9e elementor-widget elementor-widget-heading\" data-id=\"d14fb9e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Process Validation Principles (1-day)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-60d5afd elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"60d5afd\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b993e59\" data-id=\"b993e59\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f162a6b elementor-widget elementor-widget-text-editor\" data-id=\"f162a6b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h4>Instructor<\/h4><p style=\"padding-left: 30px;\"><a href=\"\/about\/\">Dr. Wayne A. Taylor<\/a><\/p><h4>Course Objective<\/h4><p style=\"padding-left: 30px;\">Teaches the basic principles and steps in performing a process validation.\u00a0 The course is based on the GHTF (Global Harmonization Task Force) process validation guidance document and other applicable references.\u00a0 It is designed for the medical device and pharmaceutical industries.<\/p><p style=\"padding-left: 30px;\">It describes the statistical tools applicable to process validation and how to integrate them into the IQ-OQ-PQ phases of validation using the <a href=\"\/six-sigma-program\/six-sigma-validation-process\/\">Six Sigma Validation process<\/a>.\u00a0 The course topics include determining key inputs, determining worst-case conditions, selecting sample sizes, control plans, handling compensating adjustments, and much more.\u00a0 Upon completion of this course, you will understand the general process for performing a process validation.<\/p><h4>Primary Audience<\/h4><p style=\"padding-left: 30px;\">This course is designed for all individuals who are involved in process validation.\u00a0 This includes engineers, manufacturing and quality supervisors, and management.\u00a0 No statistical or mathematical background is required.<\/p><h4>Course Outline<\/h4><p style=\"padding-left: 30px;\">AM<\/p><ul><li>What is Process Validation?<\/li><li>Master Validation Plan<\/li><li>Installation Qualification (IQ)<\/li><li>Operational Qualification (OQ)<\/li><li>Performance Qualification (PQ)<\/li><\/ul><p style=\"padding-left: 30px;\">PM<\/p><ul><li>Process Validation Tools<\/li><li>Control Plan<\/li><li>Process Verification<\/li><li>Master Validation Report<\/li><li>Revalidation<\/li><\/ul><h4>Prerequisites<\/h4><p style=\"padding-left: 30px;\">None.<\/p><h4>Related Courses<\/h4><p style=\"padding-left: 30px;\">This course is frequently combined with the courses below to create a comprehensive 2.5 days of training on Process Validation:<\/p><ul><li><a href=\"\/courses\/validation-sampling-plans\/\">Validation Sampling Plans<\/a> course &#8211; How many samples do I need and how can I reduce this?<\/li><li><a href=\"\/courses\/normality-testing-and-transformations\/\">Normality Testing and Transformations<\/a> course &#8211; How do I handle nonnormal data?<\/li><\/ul><h4>Reference Documents<\/h4><p style=\"padding-left: 30px;\">This course covers material found in the following reference documents:<\/p><p style=\"padding-left: 30px;\"><strong>DEVICES<\/strong><\/p><ul><li><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=820.75\" target=\"_blank\" rel=\"noopener\">Code of Federal Regulation: Title 21, Subsection H, Part 820, Section 820.75.<\/a><\/li><li><a href=\"\/federal-register-vol61-no195-pdf\/\" target=\"_blank\" rel=\"noopener\">Federal Register &#8211; Preamble Vol. 61, No. 195, October 7, 1996.<\/a><\/li><li><a href=\"\/ghtf-process-validation-guidance-edition-2-pdf\/\" target=\"_blank\" rel=\"noopener\">Global Harmonization Task Force (GHTF): \u201cQuality Management Systems &#8211; Process Validation Guidance \u2013 Edition 2,\u201d January 22, 2004.<\/a><ul><li>See <a href=\"\/methods-and-tools-for-process-validation\/\">Methods and Tools for Process Validation<\/a> appearing as Annex A\u00a0of the guidance.<\/li><\/ul><\/li><li><a href=\"\/ghtf-process-validation-guidance-edition-1-pdf\/\" target=\"_blank\" rel=\"noopener\">Global Harmonization Task Force (GHTF): \u201cQuality Management Systems &#8211; Process Validation Guidance \u2013 Edition 1,\u201d June 29, 1999.<\/a> (OBSOLETE)<\/li><li><a href=\"\/fda-design-control-guidance-1997-pdf\/\" target=\"_blank\" rel=\"noopener\">Food &amp; Drug Administration (FDA): \u201cDesign Control Guidance for Medical Device Manufacturers,\u201d March 1997.<\/a><\/li><\/ul><p style=\"padding-left: 30px;\"><strong>DRUGS<\/strong><\/p><ul><li><a href=\"\/fda-process-validation-general-principles-and-practices-2011-pdf\/\" target=\"_blank\" rel=\"noopener\">Food &amp; Drug Administration (FDA): \u201cProcess Validation: General Principles and Practices,\u201d January 2011.<\/a><\/li><li><a href=\"\/presentation-process-validation-a-lifecycle-approach-grace-mcnally-2011-pdf\/\" target=\"_blank\" rel=\"noopener\">Process Validation A Lifecycle Approach, Grace E. McNally, FDA, May 6, 2011.<\/a><\/li><li><a href=\"\/fda-process-validation-guidance-1987-pdf\/\" target=\"_blank\" rel=\"noopener\">Food &amp; Drug Administration (FDA): \u201cGuideline on General Principles of Process Validation,\u201d May 1987.<\/a> (OBSOLETE)<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Process Validation Principles (1-day) Instructor Dr. Wayne A. Taylor Course Objective Teaches the basic principles and steps in performing a process validation.\u00a0 The course is based on the GHTF (Global Harmonization Task Force) process validation guidance document and other applicable references.\u00a0 It is designed for the medical device and pharmaceutical industries. It describes the statistical [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":551,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-567","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Process Validation Principles - Taylor Enterprises<\/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:\/\/variation.com\/courses\/process-validation-principles\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Process Validation Principles - Taylor Enterprises\" \/>\n<meta property=\"og:description\" content=\"Process Validation Principles (1-day) Instructor Dr. Wayne A. Taylor Course Objective Teaches the basic principles and steps in performing a process validation.\u00a0 The course is based on the GHTF (Global Harmonization Task Force) process validation guidance document and other applicable references.\u00a0 It is designed for the medical device and pharmaceutical industries. It describes the statistical [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/variation.com\/courses\/process-validation-principles\/\" \/>\n<meta property=\"og:site_name\" content=\"Taylor Enterprises\" \/>\n<meta property=\"article:modified_time\" content=\"2021-05-31T02:52:05+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/variation.com\\\/courses\\\/process-validation-principles\\\/\",\"url\":\"https:\\\/\\\/variation.com\\\/courses\\\/process-validation-principles\\\/\",\"name\":\"Process Validation Principles - Taylor Enterprises\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/variation.com\\\/#website\"},\"datePublished\":\"2018-07-23T14:50:02+00:00\",\"dateModified\":\"2021-05-31T02:52:05+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/variation.com\\\/courses\\\/process-validation-principles\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/variation.com\\\/courses\\\/process-validation-principles\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/variation.com\\\/courses\\\/process-validation-principles\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/variation.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Courses\",\"item\":\"https:\\\/\\\/variation.com\\\/courses\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Process Validation Principles\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/variation.com\\\/#website\",\"url\":\"https:\\\/\\\/variation.com\\\/\",\"name\":\"Taylor Enterprises\",\"description\":\"Applied Statistics for Engineers and Quality for FDA-Regulated Industries\",\"publisher\":{\"@id\":\"https:\\\/\\\/variation.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/variation.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/variation.com\\\/#organization\",\"name\":\"Taylor Enterprises\",\"url\":\"https:\\\/\\\/variation.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/variation.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/variation.com\\\/wp-content\\\/uploads\\\/2018\\\/04\\\/logo-taylor-enterprises.png\",\"contentUrl\":\"https:\\\/\\\/variation.com\\\/wp-content\\\/uploads\\\/2018\\\/04\\\/logo-taylor-enterprises.png\",\"width\":500,\"height\":160,\"caption\":\"Taylor Enterprises\"},\"image\":{\"@id\":\"https:\\\/\\\/variation.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Process Validation Principles - Taylor Enterprises","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/variation.com\/courses\/process-validation-principles\/","og_locale":"en_US","og_type":"article","og_title":"Process Validation Principles - Taylor Enterprises","og_description":"Process Validation Principles (1-day) Instructor Dr. Wayne A. Taylor Course Objective Teaches the basic principles and steps in performing a process validation.\u00a0 The course is based on the GHTF (Global Harmonization Task Force) process validation guidance document and other applicable references.\u00a0 It is designed for the medical device and pharmaceutical industries. It describes the statistical [&hellip;]","og_url":"https:\/\/variation.com\/courses\/process-validation-principles\/","og_site_name":"Taylor Enterprises","article_modified_time":"2021-05-31T02:52:05+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/variation.com\/courses\/process-validation-principles\/","url":"https:\/\/variation.com\/courses\/process-validation-principles\/","name":"Process Validation Principles - Taylor Enterprises","isPartOf":{"@id":"https:\/\/variation.com\/#website"},"datePublished":"2018-07-23T14:50:02+00:00","dateModified":"2021-05-31T02:52:05+00:00","breadcrumb":{"@id":"https:\/\/variation.com\/courses\/process-validation-principles\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/variation.com\/courses\/process-validation-principles\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/variation.com\/courses\/process-validation-principles\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/variation.com\/"},{"@type":"ListItem","position":2,"name":"Courses","item":"https:\/\/variation.com\/courses\/"},{"@type":"ListItem","position":3,"name":"Process Validation Principles"}]},{"@type":"WebSite","@id":"https:\/\/variation.com\/#website","url":"https:\/\/variation.com\/","name":"Taylor Enterprises","description":"Applied Statistics for Engineers and Quality for FDA-Regulated Industries","publisher":{"@id":"https:\/\/variation.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/variation.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/variation.com\/#organization","name":"Taylor Enterprises","url":"https:\/\/variation.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/variation.com\/#\/schema\/logo\/image\/","url":"https:\/\/variation.com\/wp-content\/uploads\/2018\/04\/logo-taylor-enterprises.png","contentUrl":"https:\/\/variation.com\/wp-content\/uploads\/2018\/04\/logo-taylor-enterprises.png","width":500,"height":160,"caption":"Taylor Enterprises"},"image":{"@id":"https:\/\/variation.com\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/variation.com\/wp-json\/wp\/v2\/pages\/567","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/variation.com\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/variation.com\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/variation.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/variation.com\/wp-json\/wp\/v2\/comments?post=567"}],"version-history":[{"count":5,"href":"https:\/\/variation.com\/wp-json\/wp\/v2\/pages\/567\/revisions"}],"predecessor-version":[{"id":3858,"href":"https:\/\/variation.com\/wp-json\/wp\/v2\/pages\/567\/revisions\/3858"}],"up":[{"embeddable":true,"href":"https:\/\/variation.com\/wp-json\/wp\/v2\/pages\/551"}],"wp:attachment":[{"href":"https:\/\/variation.com\/wp-json\/wp\/v2\/media?parent=567"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}