{"id":697,"date":"2017-12-01T22:40:13","date_gmt":"2017-12-02T05:40:13","guid":{"rendered":"https:\/\/www.designcontrolconsultant.com\/?page_id=697"},"modified":"2017-12-02T15:38:55","modified_gmt":"2017-12-02T22:38:55","slug":"about-copy-copy-copy","status":"publish","type":"page","link":"https:\/\/www.designcontrolconsultant.com\/?page_id=697","title":{"rendered":"Risk Management Course Agenda"},"content":{"rendered":"<p><strong>Medical Device Risk Management (ISO 14971:2007\/2012) &#8211; Interpretation and Practical Implementation Techniques \/ 2 Days<\/strong><\/p>\n<p><strong><u>Day One <\/u><\/strong><\/p>\n<p><strong>1) Introduction to Medical Device Risk Management<\/strong><\/p>\n<ul>\n<li>Introduction<\/li>\n<li>Regulation, Guidance &amp; Standards (FDA &amp; ISO)<\/li>\n<li>Scope of ISO 14971<\/li>\n<li>Risk Management is More than Risk Analysis<\/li>\n<\/ul>\n<p><strong>2) Risk Management Terms and Definitions (ISO 14971)<\/strong><\/p>\n<ul>\n<li>General Terms and Definitions<\/li>\n<li>Conceptual Example &amp; Exercise (Man Hole)<\/li>\n<li>Risk<\/li>\n<li>Risk Assessment<\/li>\n<li>Risk Analysis<\/li>\n<li>Hazards<\/li>\n<li>Hazardous Situation<\/li>\n<li>Harm<\/li>\n<li>Risk Evaluation<\/li>\n<li>Risk Control<\/li>\n<li>Residual Risk<\/li>\n<\/ul>\n<p><strong>3) ISO 14971 \u2013 General Requirements<\/strong><\/p>\n<ul>\n<li>General Requirements for Risk Management<\/li>\n<li>Risk Management Process<\/li>\n<li>Management Responsibilities<\/li>\n<li>Qualification of Personnel<\/li>\n<li>Risk Management Plan<\/li>\n<li>Risk Management File<\/li>\n<li>Example<\/li>\n<\/ul>\n<p><strong>4) Risk Analysis<\/strong><\/p>\n<ul>\n<li>Risk Analysis<\/li>\n<li>Risk Analysis Process<\/li>\n<li>Intended Use and Identification of Characteristics Related Medical Device Safety<\/li>\n<li>Hazard Analysis<\/li>\n<li>Examples (Hazards, Hazardous Situation \u2013 ISO 14971)<\/li>\n<li>Estimate Risks for Hazardous Situations<\/li>\n<li>Exercise (Misuse)<\/li>\n<li>Quiz<\/li>\n<li>Exercise<\/li>\n<\/ul>\n<p><strong>Lunch<\/strong><\/p>\n<p><strong>\u00a05) Risk Evaluation <\/strong><\/p>\n<ul>\n<li>Risk Evaluation<\/li>\n<li>Quiz<\/li>\n<li>Exercise<\/li>\n<\/ul>\n<p><strong>6) Risk Control <\/strong><\/p>\n<ul>\n<li>Risk Control<\/li>\n<li>Risk Reduction Required<\/li>\n<li>Risk Control Option Analysis<\/li>\n<li>Implementation of Risk Control Measures<\/li>\n<li>Verification of Risk Control<\/li>\n<li>Residual Risk Evaluation<\/li>\n<li>Risk vs. Benefit Analysis<\/li>\n<li>Evaluation of Overall Residual Risk Acceptability<\/li>\n<li>Completeness of Risk Control<\/li>\n<li>Quiz<\/li>\n<li>ISO 14971 Examples<\/li>\n<li>Exercise Implement risk controls exercise<\/li>\n<\/ul>\n<p><strong><u>Day Two <\/u><\/strong><\/p>\n<p><strong>7) General Topics <\/strong><\/p>\n<ul>\n<li>Risk Management Report<\/li>\n<li>Production and Post-Production Information<\/li>\n<li>Progressive Risk Management throughout product development lifecycle<\/li>\n<li>Quiz<\/li>\n<\/ul>\n<p><strong>\u00a08) Risk Analysis Techniques <\/strong><\/p>\n<ul>\n<li>Preliminary Hazard Analysis (PHA)<\/li>\n<li>Fault Tree Analysis (FTA)<\/li>\n<li>Failure Mode and Effects Analysis (FMEA)<\/li>\n<li>Exercise<\/li>\n<\/ul>\n<p><strong>Lunch<\/strong><\/p>\n<p><strong>\u00a09) Risk Management and Design Control <\/strong><\/p>\n<ul>\n<li>Integration of Design Controls and Risk Management<\/li>\n<li>Risk Management and Human Factors<\/li>\n<li>Quiz<\/li>\n<\/ul>\n<p><strong>\u00a010) Risk Management Process Work Shop (Group Break Out)<\/strong><\/p>\n<ul>\n<li>Hazard Analysis<\/li>\n<li>Estimate Risks for Each Hazard<\/li>\n<li>Evaluate Risk<\/li>\n<li>Implement Risk Controls<\/li>\n<li>Evaluate Residual Risk<\/li>\n<\/ul>\n<p><strong>11) Final Overview of Risk Management Process (Review Flow Chart &amp; Risk Assessment)<\/strong><\/p>\n<p><strong>12) Question and Answer<\/strong><\/p>\n<p><strong>13) Course Assessment <\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Medical Device Risk Management (ISO 14971:2007\/2012) &#8211; Interpretation and Practical Implementation Techniques \/ 2 Days Day One 1) Introduction to&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-697","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>Risk Management 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=697\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Risk Management Course Agenda - Design Control &amp; Risk Management Solutions\" \/>\n<meta property=\"og:description\" content=\"Medical Device Risk Management (ISO 14971:2007\/2012) &#8211; Interpretation and Practical Implementation Techniques \/ 2 Days Day One 1) Introduction to&hellip;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.designcontrolconsultant.com\/?page_id=697\" \/>\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=\"2017-12-02T22:38:55+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=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/?page_id=697\",\"url\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/?page_id=697\",\"name\":\"Risk Management Course Agenda - Design Control &amp; Risk Management Solutions\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/#website\"},\"datePublished\":\"2017-12-02T05:40:13+00:00\",\"dateModified\":\"2017-12-02T22:38:55+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/?page_id=697#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.designcontrolconsultant.com\\\/?page_id=697\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/?page_id=697#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.designcontrolconsultant.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Risk Management 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":"Risk Management 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=697","og_locale":"en_US","og_type":"article","og_title":"Risk Management Course Agenda - Design Control &amp; Risk Management Solutions","og_description":"Medical Device Risk Management (ISO 14971:2007\/2012) &#8211; Interpretation and Practical Implementation Techniques \/ 2 Days Day One 1) Introduction to&hellip;","og_url":"https:\/\/www.designcontrolconsultant.com\/?page_id=697","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":"2017-12-02T22:38:55+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.designcontrolconsultant.com\/?page_id=697","url":"https:\/\/www.designcontrolconsultant.com\/?page_id=697","name":"Risk Management Course Agenda - Design Control &amp; Risk Management Solutions","isPartOf":{"@id":"https:\/\/www.designcontrolconsultant.com\/#website"},"datePublished":"2017-12-02T05:40:13+00:00","dateModified":"2017-12-02T22:38:55+00:00","breadcrumb":{"@id":"https:\/\/www.designcontrolconsultant.com\/?page_id=697#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.designcontrolconsultant.com\/?page_id=697"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.designcontrolconsultant.com\/?page_id=697#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.designcontrolconsultant.com\/"},{"@type":"ListItem","position":2,"name":"Risk Management 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\/697","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=697"}],"version-history":[{"count":4,"href":"https:\/\/www.designcontrolconsultant.com\/index.php?rest_route=\/wp\/v2\/pages\/697\/revisions"}],"predecessor-version":[{"id":742,"href":"https:\/\/www.designcontrolconsultant.com\/index.php?rest_route=\/wp\/v2\/pages\/697\/revisions\/742"}],"wp:attachment":[{"href":"https:\/\/www.designcontrolconsultant.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=697"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}