{"product_id":"managing-the-documentation-maze-isbn-9780470467084","title":"Managing the Documentation Maze","description":"\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  INTRODUCTION.  \u003cp\u003eABOUT THE AUTHORS.\u003c\/p\u003e \u003cp\u003eCHAPTER 1 UNDERSTANDING THE REGULATIONS.\u003c\/p\u003e \u003cp\u003eCHAPTER 2 PEOPLE, PROCESS, AND DOCUMENTATION.\u003c\/p\u003e \u003cp\u003eCHAPTER 3 PRINCIPLES OF DOCUMENT MANAGEMENT.\u003c\/p\u003e \u003cp\u003eCHAPTER 4 DECIDING TO GO ELECTRONIC AND FINDING A VENDOR.\u003c\/p\u003e \u003cp\u003eCHAPTER 5 MAKING THE TRANSITION FROM HYBRID TO VALIDATED E-SYSTEM.\u003c\/p\u003e \u003cp\u003eCHAPTER 6 PART 11 COMPLIANCE.\u003c\/p\u003e \u003cp\u003eCHAPTER 7 STANDARD OPERATING PROCEDURES.\u003c\/p\u003e \u003cp\u003eCHAPTER 8 NONCLINICAL RECORDS.\u003c\/p\u003e \u003cp\u003eCHAPTER 9 CLINICAL AND SUBMISSION RECORDS.\u003c\/p\u003e \u003cp\u003eCHAPTER 10 CONSISTENCY AND READABILITY IN DOCUMENTS.\u003c\/p\u003e \u003cp\u003eCHAPTER 11 MAINTAINING THE SYSTEM.\u003c\/p\u003e \u003cp\u003eCHAPTER 12 MAINTAINING INSPECTION READINESS.\u003c\/p\u003e \u003cp\u003eCHAPTER 13 RESOURCES.\u003c\/p\u003e \u003cp\u003eAPPENDIX.\u003c\/p\u003e \u003cp\u003eFEDERAL REGISTER.\u003c\/p\u003e \u003cp\u003eGUIDANCE FOR INDUSTRY.\u003c\/p\u003e \u003cp\u003eINDEX.\u003c\/p\u003e  \"Managing the Document Maze takes a fascinating and extremely effective approach to its topic . . . this organisational framework makes it very easy to target information that will answer specific questions of interest to the reader, while also providing a comprehensive overview of key information . . .Managing the Document Maze is recommended to readers, and receives the JCS Library Award.\" (Journal for Clinical Studies, 1 July 2010)  \u003cp\u003e \u003c\/p\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  \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  \"\u003ci\u003eManaging the Documentation Maze\u003c\/i\u003e is an excellent reference source in an easy-to-follow Q\u0026amp;A format for all healthcare professionals involved in the drug discovery process, development and manufacture of therapeutic products. Questions regarding all aspects of document management, validation, regulatory compliance, transition to electronic systems are clearly answered is an uncomplicated style by the authors, based on their extensive industry experience. I would, therefore, highly recommend this handy guide to all healthcare professional as 'Aide-mémoire', to quickly resolve and comply with rigorous regulatory standards required of the industry today.\"\u003cbr\u003e —\u003cb\u003eTom Blackburn\u003c\/b\u003e, TPBioventures, LLC","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989568372965,"sku":"NP9780470467084","price":129.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780470467084.jpg?v=1761784632","url":"https:\/\/k12savings.com\/es\/products\/managing-the-documentation-maze-isbn-9780470467084","provider":"K12savings","version":"1.0","type":"link"}