{"id":1150,"date":"2018-06-19T22:06:14","date_gmt":"2018-06-20T04:06:14","guid":{"rendered":"https:\/\/www.designcontrolconsultant.com\/?page_id=1150"},"modified":"2019-03-03T20:14:05","modified_gmt":"2019-03-04T03:14:05","slug":"design-controls-training-2","status":"publish","type":"page","link":"https:\/\/www.designcontrolconsultant.com\/?page_id=1150","title":{"rendered":"Design Controls &#038; Risk Management Combined Course"},"content":{"rendered":"\n\t\t<h3>Design Controls &#038; Risk Management<\/h3>\t\t\n\t\t\t<h3><em>An Integrated Product Development Approach<\/em><\/h3>\n<p>The course\u00a0is\u00a02 days of intensive\u00a0workshop instruction which provides\u00a0an integrated analysis\u00a0of design control &amp; risk management regulation concepts (21 CFR 820.30\/ISO 13485 \/ ISO 14971) in a product development context. The course agenda walks attendees through a typical product development lifecycle which is broken out into five development phases. Workshops, exercises and quizzes are introduced throughout the course to reinforce principles and to provide attendees with a practical and hands-on\u00a0experience.<\/p>\n<p>This workshop is appropriate for medical device professionals with minimal\u00a0to moderate experience with design control regulation. This course uses a unique blend of instruction from industry experts and\u00a0resources from FDA regulation and guidance.\u00a0\u00a0<\/p>\n\t<p><a href=\"https:\/\/www.designcontrolconsultant.com\/?page_id=1558\" target=\"_blank\" rel=\"noopener noreferrer\"><strong>Design Controls, Risk Managment &amp; Process Validation For Medical Device Professionals Handbook<\/strong><\/a><\/p>\n<p><a href=\"https:\/\/www.designcontrolconsultant.com\/?page_id=1558\" target=\"_blank\" rel=\"noopener noreferrer\"><strong> Included With Each Course<\/strong><\/a><\/p>\n<p>($170 value) (440 pages)<strong> <a href=\"https:\/\/www.amazon.com\/Controls-Management-Process-Validation-Professionals\/dp\/0692835415\/ref=sr_1_3?ie=UTF8&amp;qid=1511459802&amp;sr=8-3&amp;keywords=design+control\" target=\"_blank\" rel=\"noopener noreferrer\">(see Amazon)<\/a><\/strong><\/p>\n\t\t\t\t<a href=\"https:\/\/www.designcontrolconsultant.com\/?page_id=447\" target=\"_blank\" rel=\"noopener noreferrer\"  itemprop=\"url\">\n\t\t\t\t<img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.designcontrolconsultant.com\/wp-content\/uploads\/2017\/11\/DC-Book.jpg\" alt=\"Free Design Control &amp; Risk Management Handbook\" itemprop=\"image\" height=\"253\" width=\"195\" title=\"DC Book\" onerror=\"this.style.display='none'\"  \/>\n\t\t\t\t<\/a>\n\t\tFree Design Control &#038; Risk Management Handbook\n\t\t<h3>Contact Us<\/h3>\n\t\t<p>Contact us for more information or for an onsite\/custom training quote&#8230;<\/p>\n\t\t\t<a href=\"https:\/\/www.designcontrolconsultant.com\/?page_id=19\" target=\"_self\" role=\"button\" rel=\"noopener noreferrer\">\n\t\t\t\t\t\t\tContact Us\n\t\t\t\t\t<\/a>\n\t\t<h3>Training Options<\/h3>\n\t\t<p>Learn more about our online or on-site training options&#8230;<\/p>\n\t\t\t<a href=\"https:\/\/www.designcontrolconsultant.com\/?page_id=1629\" target=\"_blank\" role=\"button\" rel=\"noopener noreferrer\" >\n\t\t\t\t\t\t\tTraining Options\n\t\t\t\t\t<\/a>\n\t\t<h3>Course Agenda<\/h3>\n\t\t\t<a href=\"https:\/\/www.designcontrolconsultant.com\/?page_id=1155\" target=\"_self\" role=\"button\" rel=\"noopener noreferrer\">\n\t\t\t\t\t\t\tAgenda\n\t\t\t\t\t<\/a>\n\t\t<h3>Instructor Bio<\/h3>\n\t\t\t<a href=\"https:\/\/www.designcontrolconsultant.com\/?page_id=613\" target=\"_self\" role=\"button\" rel=\"noopener noreferrer\">\n\t\t\t\t\t\t\tInstructor Bio\n\t\t\t\t\t<\/a>\n\t\t\t\t<img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.designcontrolconsultant.com\/wp-content\/uploads\/2017\/12\/Training-Experience-2.jpg\" alt=\"Training Experience 2\" itemprop=\"image\" height=\"194\" width=\"259\" title=\"Training Experience 2\" onerror=\"this.style.display='none'\"  \/>\n\t<p><strong>Other Course Offerings<\/strong><\/p>\n<ul>\n<li><strong><a href=\"?page_id=508\">Design Control &#8211; Basic\/Intermediate&#8230;<\/a><\/strong><\/li>\n<li><strong><a href=\"?page_id=694\">Risk Managment (ISO 14971) Basic\/Intermediate&#8230;<\/a><\/strong><\/li>\n<\/ul>\n\t<h3><strong>Course Objectives<\/strong><\/h3>\n<ul>\n<li>Gain a solid understanding of design control and risk management regulation concepts<\/li>\n<li>Develop a\u00a0skill set for implementing design controls and risk management best practices<\/li>\n<li>Learn how to integrate design control and risk management regulation into the project management process<\/li>\n<li>Learn how to integrate a phased development approach into the product development lifecycle<\/li>\n<li>Develop methods for integrating risk management across all design control elements<\/li>\n<li>Recognize the differences between 21 CFR 820.30 and ISO 13485 design controls<\/li>\n<\/ul>\n<h3><strong> Included with the Course<\/strong><\/h3>\n<ul>\n<li>A free copy of:\u00a0<strong><a href=\"?page_id=447\"><em>Design Controls, Risk Managment and Process Validation for Medical Device Professionals<\/em><\/a><\/strong><a href=\"design-controls-reference-handbook.html\" target=\"\" rel=\"noopener noreferrer\">\u00a0<\/a>(2016 v.1) (440+ pages) ($170 value)<\/li>\n<li>Extensive course notes and power point presentation<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Design Controls &#038; Risk Management An Integrated Product Development Approach The course\u00a0is\u00a02 days of intensive\u00a0workshop instruction which provides\u00a0an integrated analysis\u00a0of&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-1150","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>Design Controls &amp; Risk Management Combined Course - Design Control &amp; Risk Management Solutions<\/title>\n<meta name=\"description\" content=\"Specializing in FDA &amp; ISO13485 design controls training for medical device professionals. 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