{"id":619,"date":"2017-11-30T18:50:15","date_gmt":"2017-12-01T01:50:15","guid":{"rendered":"https:\/\/www.designcontrolconsultant.com\/?page_id=619"},"modified":"2018-06-19T21:23:39","modified_gmt":"2018-06-20T03:23:39","slug":"about-copy-copy","status":"publish","type":"page","link":"https:\/\/www.designcontrolconsultant.com\/?page_id=619","title":{"rendered":"Design Controls Course Agenda"},"content":{"rendered":"<p><strong>Design Controls (Basic\/Intermediate) Course Agenda \/ 2 Days<\/strong><\/p>\n<p><strong><u>Day One <\/u><\/strong><\/p>\n<p><strong>1) Introduction <\/strong><\/p>\n<ul>\n<li>Instructor and Class\u00a0Introductions<\/li>\n<li>Course Objectives &amp; Expectations<\/li>\n<li>Review Participant Objectives<\/li>\n<\/ul>\n<p><strong>2)\u00a0Overview of Design <\/strong><\/p>\n<ul>\n<li>What is Design Control? (Concepts Defined)<\/li>\n<li>The History of Design Control<\/li>\n<li>Why is Design Control important?<\/li>\n<li>FDA\u2019s Cradle to Grave Vision of the Total Product Life Cycle<\/li>\n<li>Timing of Design Control Elements During Product Development<\/li>\n<li>The \u201cUnwritten Laws\u201d of Design Control (Planning, Documentation, Risk Based Approach, Interactions)<\/li>\n<li>Relationship of Design Control Elements (The Design Control Relationship Web)<\/li>\n<li>Medical Device Class (I,II,III)<\/li>\n<li>Quiz<\/li>\n<\/ul>\n<p><strong>3)\u00a0FDA Regulation, Guidance and Other Industry Standards and\u00a0Resources <\/strong><\/p>\n<ul>\n<li>21 CFR 820.30 Regulation<\/li>\n<li>Design Control Guidance<\/li>\n<li>Quality System Preamble<\/li>\n<li>ISO 13485 (A comparison with 21 CFR 820.30)<\/li>\n<\/ul>\n<p><strong>\u00a0<\/strong><strong>4) Design and Development Planning <\/strong><\/p>\n<ul>\n<li>Why does FDA require planning?<\/li>\n<li>Design and Development Planning Regulation Review and Interpretation<\/li>\n<li>Developing Practical Design and Development Plans<\/li>\n<li>Topics Addressed in DDP<\/li>\n<li>Example<\/li>\n<li>Quiz<\/li>\n<\/ul>\n<p><strong>5) Design Input <\/strong><\/p>\n<ul>\n<li>Conceptual Example<\/li>\n<li>Design Input Regulation Review and Interpretation<\/li>\n<li>Purpose of Design Inputs<\/li>\n<li>Concept Documents vs. Design Inputs<\/li>\n<li>Quiz<\/li>\n<\/ul>\n<p><strong>Lunch <\/strong><\/p>\n<ul>\n<li>Types of Design Input (design requirements, user needs, etc)<\/li>\n<li>Examples<\/li>\n<li>The Process of Developing Effective Design Inputs (design req. and user needs)<\/li>\n<li>Design Inputs &amp; Human Factors<\/li>\n<li>Quiz<\/li>\n<li><strong>Workshop Exercise: Developing Effective Design Inputs (Group Break Out) <\/strong><\/li>\n<\/ul>\n<p><strong>6) Design Output <\/strong><\/p>\n<ul>\n<li>Conceptual Example<\/li>\n<li>Regulation Interpretation<\/li>\n<li>What are Design Outputs?\u00a0What are\u00a0Essential Design Outputs?<\/li>\n<li>Examples<\/li>\n<li>Effectively Documenting Design Outputs<\/li>\n<li>What is the Device Master Record?<\/li>\n<li>Quiz<\/li>\n<li>Exercise<\/li>\n<\/ul>\n<p><strong>8) Question and Answer Session <\/strong><\/p>\n<p><strong><u>Day Two\u00a0<\/u><\/strong><\/p>\n<p><strong>9)\u00a0Design Review <\/strong><\/p>\n<ul>\n<li>Design Review Regulation and Interpretation<\/li>\n<li>Purpose of Design Reviews<\/li>\n<li>Reviewer Roles<\/li>\n<li>Documenting Design Reviews<\/li>\n<li>Formal vs. Informal Reviews<\/li>\n<li>Types of Design Reviews<\/li>\n<li>Examples<\/li>\n<li>Characteristics of Effective Design Reviews<\/li>\n<li>Practical Implementation and Best Practices<\/li>\n<li>Quiz<\/li>\n<li>Exercise<\/li>\n<\/ul>\n<p><strong>10)\u00a0Design Verification <\/strong><\/p>\n<ul>\n<li>Conceptual Example<\/li>\n<li>Design Verification Regulation Review and Interpretation<\/li>\n<li>Purpose of Design Verification<\/li>\n<li>Types of Verification<\/li>\n<li>Verification Planning<\/li>\n<li>Documenting Verification: Protocol and Report Designs<\/li>\n<li>Examples<\/li>\n<li>Practical Implementation and Best Practices<\/li>\n<li>Quiz<\/li>\n<li><strong>Workshop Exercise: Effectively Plan and Execute Verification\u00a0<\/strong><strong>(Group Break Out)<\/strong><\/li>\n<\/ul>\n<p><strong>11) Design Validation <\/strong><\/p>\n<ul>\n<li>Conceptual Example<\/li>\n<li>Design Validation Regulation Review and Interpretation<\/li>\n<li>Purpose of Design Validation<\/li>\n<li>Validation vs. Verification (What&#8217;s\u00a0the difference?)<\/li>\n<li>Types of Validation<\/li>\n<li>Examples<\/li>\n<\/ul>\n<p><strong>Lunch <\/strong><\/p>\n<ul>\n<li>Risk Analysis (ISO 14971 Risk Management)<\/li>\n<li>Software Validation<\/li>\n<li>Is Process Validation a Part of Design Validation?<\/li>\n<li>Validation Planning &amp; Human Factors: A Risk Based Approach<\/li>\n<li>Documenting Validations: Protocol and Report Designs<\/li>\n<li>Practical Implementation and Best Practices<\/li>\n<li>Quiz<\/li>\n<li><strong>Workshop Exercise: Effectively Plan and Execute Validations\u00a0<\/strong><strong>(Group Break Out)<\/strong><\/li>\n<\/ul>\n<p><strong>12) Design Transfer\u00a0<\/strong><\/p>\n<ul>\n<li>Design Transfer Regulation Review and Interpretation<\/li>\n<li>Purpose of Design Transfer<\/li>\n<li>Three Key Components of Effective Design Transfer Procedures<\/li>\n<li>Documenting Design Transfer Activities and Deliverables<\/li>\n<li>Design Transfer: It&#8217;s a Process, Not an Event!<\/li>\n<li>The Design Transfer Process: Planning, Execution, Qualification<\/li>\n<li>Example \/ Template<\/li>\n<li>The Design Transfer Team and Design Transfer\u00a0Reviews<\/li>\n<li>Practical Implementation and Best Practices<\/li>\n<li>Quiz<\/li>\n<li>Exercise<strong>\u00a0 \u00a0<\/strong><\/li>\n<\/ul>\n<p><strong>13) Design Change <\/strong><\/p>\n<ul>\n<li>Design Change Regulation Review and Interpretation<\/li>\n<li>Purpose of Design Change<\/li>\n<li>Document Control vs. Change Control<\/li>\n<li>When Should Design Change Begin?<\/li>\n<li>Design Change Process (Development vs. Production)<\/li>\n<li>Elements of Effective Design Change<\/li>\n<li>Practical Implementation, Best Practices, and Examples<\/li>\n<li>Quiz<\/li>\n<li>Example<\/li>\n<\/ul>\n<p><strong>14) Design History File (DHF) <\/strong><\/p>\n<ul>\n<li>Design History File Regulation Review and Interpretation<\/li>\n<li>Purpose of the Design History File<\/li>\n<li>Contents of a Design History File and Record<\/li>\n<li>Examples<\/li>\n<li>DHF vs. DMR vs. DHR<\/li>\n<li>Quiz<\/li>\n<\/ul>\n<p><strong>15) Question and Answer Session <\/strong><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Design Controls (Basic\/Intermediate) Course Agenda \/ 2 Days Day One 1) Introduction Instructor and Class\u00a0Introductions Course Objectives &amp; Expectations Review&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"class_list":["post-619","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Design Controls Course Agenda - Design Control &amp; Risk Management Solutions<\/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.designcontrolconsultant.com\/?page_id=619\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Design Controls Course Agenda - Design Control &amp; Risk Management Solutions\" \/>\n<meta property=\"og:description\" content=\"Design Controls (Basic\/Intermediate) Course Agenda \/ 2 Days Day One 1) Introduction Instructor and Class\u00a0Introductions Course Objectives &amp; Expectations Review&hellip;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.designcontrolconsultant.com\/?page_id=619\" \/>\n<meta property=\"og:site_name\" content=\"Design Control &amp; Risk Management Solutions\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/Procenius-1974504349471824\/?hc_ref=ARSrg921s8qIUi7RmXjCi5OeFmgLFLa0UseiwbZNYXH6saQXIHMTHNRPwr_F4LHaTGo&amp;amp%3bamp%3bamp%3bamp%3bfref=nf\" \/>\n<meta property=\"article:modified_time\" content=\"2018-06-20T03:23:39+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=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/?page_id=619\",\"url\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/?page_id=619\",\"name\":\"Design Controls Course Agenda - Design Control &amp; Risk Management Solutions\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/#website\"},\"datePublished\":\"2017-12-01T01:50:15+00:00\",\"dateModified\":\"2018-06-20T03:23:39+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/?page_id=619#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.designcontrolconsultant.com\\\/?page_id=619\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/?page_id=619#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Design Controls Course Agenda\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/#website\",\"url\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/\",\"name\":\"Procenius\",\"description\":\"PROCENIUS CONSULTING | Medical Device Design Control &amp; Risk Management Training and Consulting\",\"publisher\":{\"@id\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/#organization\",\"name\":\"Procenius\",\"url\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/wp-content\\\/uploads\\\/2017\\\/11\\\/Procenius-Symbol.jpg\",\"contentUrl\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/wp-content\\\/uploads\\\/2017\\\/11\\\/Procenius-Symbol.jpg\",\"width\":80,\"height\":84,\"caption\":\"Procenius\"},\"image\":{\"@id\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/Procenius-1974504349471824\\\/?hc_ref=ARSrg921s8qIUi7RmXjCi5OeFmgLFLa0UseiwbZNYXH6saQXIHMTHNRPwr_F4LHaTGo&amp;amp;amp;amp;fref=nf\",\"https:\\\/\\\/www.linkedin.com\\\/in\\\/vern-geckler-mba-ms-pmp-68928028\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Design Controls Course Agenda - Design Control &amp; Risk Management Solutions","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:\/\/www.designcontrolconsultant.com\/?page_id=619","og_locale":"en_US","og_type":"article","og_title":"Design Controls Course Agenda - Design Control &amp; Risk Management Solutions","og_description":"Design Controls (Basic\/Intermediate) Course Agenda \/ 2 Days Day One 1) Introduction Instructor and Class\u00a0Introductions Course Objectives &amp; Expectations Review&hellip;","og_url":"https:\/\/www.designcontrolconsultant.com\/?page_id=619","og_site_name":"Design Control &amp; Risk Management Solutions","article_publisher":"https:\/\/www.facebook.com\/Procenius-1974504349471824\/?hc_ref=ARSrg921s8qIUi7RmXjCi5OeFmgLFLa0UseiwbZNYXH6saQXIHMTHNRPwr_F4LHaTGo&amp%3bamp%3bamp%3bamp%3bfref=nf","article_modified_time":"2018-06-20T03:23:39+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.designcontrolconsultant.com\/?page_id=619","url":"https:\/\/www.designcontrolconsultant.com\/?page_id=619","name":"Design Controls Course Agenda - Design Control &amp; Risk Management Solutions","isPartOf":{"@id":"https:\/\/www.designcontrolconsultant.com\/#website"},"datePublished":"2017-12-01T01:50:15+00:00","dateModified":"2018-06-20T03:23:39+00:00","breadcrumb":{"@id":"https:\/\/www.designcontrolconsultant.com\/?page_id=619#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.designcontrolconsultant.com\/?page_id=619"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.designcontrolconsultant.com\/?page_id=619#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.designcontrolconsultant.com\/"},{"@type":"ListItem","position":2,"name":"Design Controls Course Agenda"}]},{"@type":"WebSite","@id":"https:\/\/www.designcontrolconsultant.com\/#website","url":"https:\/\/www.designcontrolconsultant.com\/","name":"Procenius","description":"PROCENIUS CONSULTING | Medical Device Design Control &amp; Risk Management Training and Consulting","publisher":{"@id":"https:\/\/www.designcontrolconsultant.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.designcontrolconsultant.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.designcontrolconsultant.com\/#organization","name":"Procenius","url":"https:\/\/www.designcontrolconsultant.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.designcontrolconsultant.com\/#\/schema\/logo\/image\/","url":"https:\/\/www.designcontrolconsultant.com\/wp-content\/uploads\/2017\/11\/Procenius-Symbol.jpg","contentUrl":"https:\/\/www.designcontrolconsultant.com\/wp-content\/uploads\/2017\/11\/Procenius-Symbol.jpg","width":80,"height":84,"caption":"Procenius"},"image":{"@id":"https:\/\/www.designcontrolconsultant.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/Procenius-1974504349471824\/?hc_ref=ARSrg921s8qIUi7RmXjCi5OeFmgLFLa0UseiwbZNYXH6saQXIHMTHNRPwr_F4LHaTGo&amp;amp;amp;amp;fref=nf","https:\/\/www.linkedin.com\/in\/vern-geckler-mba-ms-pmp-68928028"]}]}},"_links":{"self":[{"href":"https:\/\/www.designcontrolconsultant.com\/index.php?rest_route=\/wp\/v2\/pages\/619","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.designcontrolconsultant.com\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.designcontrolconsultant.com\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.designcontrolconsultant.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.designcontrolconsultant.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=619"}],"version-history":[{"count":2,"href":"https:\/\/www.designcontrolconsultant.com\/index.php?rest_route=\/wp\/v2\/pages\/619\/revisions"}],"predecessor-version":[{"id":621,"href":"https:\/\/www.designcontrolconsultant.com\/index.php?rest_route=\/wp\/v2\/pages\/619\/revisions\/621"}],"wp:attachment":[{"href":"https:\/\/www.designcontrolconsultant.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=619"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}