{"product_id":"managing-the-documentation-maze-9780470467084","title":"Managing the Documentation Maze","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\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, biolo\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\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\n\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003eINTRODUCTION.  \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\n\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49525375238487,"sku":"9780470467084","price":95.9,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9780470467084.jpg?v=1731860277","url":"https:\/\/bookcurl.com\/products\/managing-the-documentation-maze-9780470467084","provider":"Book Curl","version":"1.0","type":"link"}