{"product_id":"9780470467084","title":"Managing the Documentation Maze Answers to Questions You Didn't Even Know to Ask","description":"\u003ch1\u003eManaging the Documentation Maze\u003c\/h1\u003e\u003ch2\u003eAnswers to Questions You Didn't Even Know to Ask\u003c\/h2\u003e\u003ch3\u003eJanet Gough | David Nettleton\u003c\/h3\u003e\u003cdiv\u003e\u003cb\u003eTechnology \u0026amp; Engineering \/ Quality Control\u003c\/b\u003e\u003c\/div\u003e\u003cbr\u003e\u003cdiv\u003e\n\u003cb\u003eThe accessible, easy-to-follow guide that demystifies documentation management\u003c\/b\u003e  \u003cp\u003eWhen it comes to receiving documentation to confirm good science, U.S. and international regulators place high demands on the healthcare industry. As a result, companies developing and manufacturing therapeutic products must implement a strategy that allows them to properly manage their records and documents, since they must comply with rigorous standards and be available for regulatory review or inspection at a moment’s notice.\u003c\/p\u003e \u003cp\u003eWritten in a user-friendly Q\u0026amp;A style for quick reference, \u003ci\u003eManaging the Documentation Maze\u003c\/i\u003e provides answers to 750 questions the authors encounter frequently in their roles as consultants and trainers. In simple terms, this handy guide breaks down the key components that facilitate successful document management, and shows why it needs to be a core discipline in the industry with information on:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eCompliance with regulations in pharmaceutical, biological, and device record keeping\u003c\/li\u003e \u003cli\u003eElectronic systems, hybrid systems, and the entire scope of documentation that companies must manage\u003c\/li\u003e \u003cli\u003eHow to write and edit documents that meet regulatory compliance\u003c\/li\u003e \u003cli\u003eMaking the transition to an electronic system, including how to validate and document the process\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eAnyone responsible for managing documents in the health field will find this book to be a trusted partner in unraveling the bureaucratic web of confusion, while it initiates a plan on how to put an effective, lasting system in place—one that will stand up to any type of scrutiny. \u003c\/p\u003e\n\u003c\/div\u003e\u003cdiv\u003e  \u003cb\u003eJanet Gough\u003c\/b\u003e has extensive experience as a consultant to the pharmaceutical, biotech, and medical device industries. She designs systems for compliance with binding regulations, and conducts training accordingly. She assists companies in the preparation of documents including development reports, procedures, clinical documents, and regulatory fillings. Ms. Gough is the author of seven other books.  \u003cp\u003e\u003cb\u003eDavid Nettleton\u003c\/b\u003e is a compliance, documentation, and computer system validation consultant involved with the development, purchase, installation, operation, project management, and maintenance of computerized systems used in regulated applications (GMP, GCP, and GLP). He is the author of three other books.\u003c\/p\u003e\n\u003c\/div\u003e\u003cbr\u003e\u003ctable\u003e\n\u003ctr\u003e\n\u003ctd\u003ePublication Date: \u003c\/td\u003e\n\u003ctd\u003e22 March 2010\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003ePublisher: \u003c\/td\u003e\n\u003ctd\u003eWiley\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eImprint: \u003c\/td\u003e\n\u003ctd\u003eWiley\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eISBN-13: \u003c\/td\u003e\n\u003ctd\u003e9780470467084\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eFormat: \u003c\/td\u003e\n\u003ctd\u003eHardback\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003ePage Count: \u003c\/td\u003e\n\u003ctd\u003e488\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eWeight (oz): \u003c\/td\u003e\n\u003ctd\u003e29.28\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/table\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":44310842179724,"sku":"9780470467084","price":120.56,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0710\/9545\/1788\/files\/9780470467084.jpg?v=1780112938","url":"https:\/\/fh90cf-fv.myshopify.com\/products\/9780470467084","provider":"Late Knight Books and Services, LLC","version":"1.0","type":"link"}