Excellence Beyond Compliance: Establishing a Medical Device Quality System by Wi

Description: Excellence Beyond Compliance by William I. White Estimated delivery 3-12 business days Format Hardcover Condition Brand New Description Many companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious kind of noncompliance. Documentation created with compliance as the sole consideration often ends up confusing the employees who must use the documentation.This book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. This book also never forgets that real people must make any QMS work; the book provides a blueprint for creating a QMS that real people will find useful.After a review of the challenges that any medical device company faces in the world of today—the multiple sources of QMS requirements—the book poses a question: are we satisfied with the QMS we have now, or could we do better? If we want to do better, this book can help.This book offers: Advice that will lead to an effective and efficient QMS. Detailed guidance on the key decisions to be made regarding the quality system being established. Detailed ideas on how to execute those decisions. Up-to-date information on compliance to current regulations and standards and guidance on staying up to date. Specific examples of procedures. Information regarding requirements for combination products, such as a drug + device combination. Advice on incorporating risk management in the QMS. Author Biography Bill White started Quality System Strategies LLC in 2006 after 30 years at Bayer HealthCare LLC. At Bayer, after 20 years in R&D he worked with colleagues in the mid 1990s to establish the design control system for the diagnostics division. He then became Manager, Quality Systems Strategy, and in that role served as principal architect for the worldwide quality system of the division.Since retiring from Bayer, he has advised medical device companies ranging in size from a few persons to several thousand persons on how best to fulfill requirements of 21 CFR 820 and ISO 13485 while creating quality systems that serve the needs of the companies and their employees.Dr. White holds an A.B. in Chemistry from Harvard College and a PhD in Chemistry from Cornell University. Details ISBN 1138491470 ISBN-13 9781138491472 Title Excellence Beyond Compliance Author William I. White Format Hardcover Year 2018 Pages 216 Publisher Taylor & Francis Ltd GE_Item_ID:139847316; About Us Grand Eagle Retail is the ideal place for all your shopping needs! With fast shipping, low prices, friendly service and over 1,000,000 in stock items - you're bound to find what you want, at a price you'll love! Shipping & Delivery Times Shipping is FREE to any address in USA. Please view eBay estimated delivery times at the top of the listing. Deliveries are made by either USPS or Courier. We are unable to deliver faster than stated. International deliveries will take 1-6 weeks. NOTE: We are unable to offer combined shipping for multiple items purchased. This is because our items are shipped from different locations. Returns If you wish to return an item, please consult our Returns Policy as below: Please contact Customer Services and request "Return Authorisation" before you send your item back to us. Unauthorised returns will not be accepted. Returns must be postmarked within 4 business days of authorisation and must be in resellable condition. Returns are shipped at the customer's risk. We cannot take responsibility for items which are lost or damaged in transit. For purchases where a shipping charge was paid, there will be no refund of the original shipping charge. Additional Questions If you have any questions please feel free to Contact Us. Categories Baby Books Electronics Fashion Games Health & Beauty Home, Garden & Pets Movies Music Sports & Outdoors Toys

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