{"id":447,"date":"2017-11-23T21:26:46","date_gmt":"2017-11-24T04:26:46","guid":{"rendered":"https:\/\/www.designcontrolconsultant.com\/?page_id=447"},"modified":"2019-01-07T23:51:46","modified_gmt":"2019-01-08T06:51:46","slug":"free-design-control-and-risk-management-reference-book","status":"publish","type":"page","link":"https:\/\/www.designcontrolconsultant.com\/?page_id=447","title":{"rendered":"Free Design Control &#038; Risk Management Reference Book"},"content":{"rendered":"\n\t<p><strong>Free Design Control &amp; Risk Management Reference Book<\/strong><\/p>\n<p>In addition\u00a0to the training materials, a free design controls, risk management &amp; process validation reference book is included with every training course (<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\"><em>Design Controls, Risk Management &amp; Process Validation for Medical Device Professionals<\/em>;\u00a0$170 value as sold on Amazon.com<\/a>) Author:<\/strong>\u00a0<strong><a href=\"https:\/\/www.designcontrolconsultant.com\/?page_id=2\" target=\"_blank\" rel=\"noopener\">Vern Geckler<\/a><\/strong><\/p>\n<p>&nbsp;<\/p>\n\t<ul>\n<li>FDA Regulation\u00a0Cross Referencing<\/li>\n<li>Project Management Integration<\/li>\n<li>Practical Best Practices &amp; Templates<\/li>\n<li>Case Studies &amp; Examples<\/li>\n<li>Regulation, Guidance and Preamble Included<\/li>\n<li>440+ \u00a0Pages (8.5 X 11)<\/li>\n<li>Design Controls (21 CFR 820.30)<\/li>\n<li>Risk Management (ISO 14971)<\/li>\n<li>Process Validation (21 CFR 820.75)<\/li>\n<li>$170 value<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n\t\t<h3>Design Control &#038; Risk Managment Reference Book<\/h3>\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\"  \/>\n\t\t\t<p><strong><a href=\"https:\/\/www.amazon.com\/Controls-Management-Process-Validation-Professionals\/dp\/0692835415\/ref=sr_1_4?ie=UTF8&amp;qid=1546826874&amp;sr=8-4&amp;keywords=design+control+book\" target=\"_blank\" rel=\"noopener\">Purchase on Amazon Now!<\/a><\/strong><\/p>\n\t<strong>Purpose of the Book<\/strong><br \/>\n Over the last two decades since the design control regulation was introduced, the valuable\u00a0 and detailed knowledge for implementing design control systems, outside the walls of the FDA, has been retained in the minds of a group of medical device industry consultants which varies greatly depending on the consultant\u2019s experience.\n<p>The purpose of this book is to capture the last two decades of design control expertise from industry experts and through detail interpretation of design control regulation and guidance. This book is a download of the author\u2019s experience and industry expert\u2019s\u00a0knowledge of design control best practices and practical implementation guidance which is cross-referenced with the regulation, design control guidance, and quality system preamble.<\/p>\n<p>This book is also intended to provide medical device professionals with one point of reference when trying to understand medical device regulation. There are numerous medical device new product development regulations, standards and guidance documents that are scattered across the FDA website and internet. It can be quite a daunting task to understand them all. This book attempts to bring all of those resources together either by reference or by including the actual document in this book when possible.<\/p>\n<p>This book was also written to provide additional guidance, interpretation, examples and case studies to help medical device professionals solidify their understanding of medical device regulation.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Free Design Control &amp; Risk Management Reference Book In addition\u00a0to the training materials, a free design controls, risk management &amp;&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-447","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>Free Design Control &amp; 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