{"product_id":"cost-contained-regulatory-compliance-for-the-pharmaceutical-biologics-and-medical-device-industries-hardback-9780470552353","title":"Cost-Contained Regulatory Compliance; For the Pharmaceutical, Biologics, and Medical Device Industries (Hardback) 9780470552353","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eCost-Contained Regulatory Compliance\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003eFor the Pharmaceutical, Biologics, and Medical Device Industries\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eSandy Weinberg (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780470552353, Wiley\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 13 May 2011\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e296 pages\u003cbr\u003e24.3 x 16.1 x 2.1 cm, 0.59 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003eThis book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003ci\u003ePREFACE.\u003c\/i\u003e  \u003cp\u003eChapter 1. Controlling Regulatory Costs.\u003c\/p\u003e \u003cp\u003eChapter 2. Clear Operation Definitions of Requirements.\u003c\/p\u003e \u003cp\u003eChapter 3. Pre-Regulatory Audits.\u003c\/p\u003e \u003cp\u003eChapter 4. Quality by Design.\u003c\/p\u003e \u003cp\u003eChapter 5. Outsourcing.\u003c\/p\u003e \u003cp\u003eChapter 6. Electronic Submissions.\u003c\/p\u003e \u003cp\u003eChapter 7. EMEA\/FDA Inspections.\u003c\/p\u003e \u003cp\u003eChapter 8. Managing FDA Inspections.\u003c\/p\u003e \u003cp\u003eChapter 9. Risk Assessment.\u003c\/p\u003e \u003cp\u003eChapter 10. Cases.\u003c\/p\u003e \u003cp\u003eChapter 11. Cost Containment Analysis.\u003c\/p\u003e \u003cp\u003eChapter 12. Managing Regulation In Times of Chaos.\u003c\/p\u003e \u003cp\u003eChapter 13. International Regulation.\u003c\/p\u003e \u003cp\u003eChapter 14. Cost Contained Regulatory Compliance.\u003c\/p\u003e \u003cp\u003eChapter 15. Future.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eBIBLIOGRAPHY.\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003ci\u003eINDEX .\u003c\/i\u003e\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Chemistry [\u003ca title=\"See our other books on Chemistry\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Chemistry%20%5BPN%5D%22\"\u003ePN\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Wiley","offers":[{"title":"Brand New","offer_id":52276363231512,"sku":"9780470552353","price":78.89,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/files\/9780470552353.jpg?v=1781367441","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/cost-contained-regulatory-compliance-for-the-pharmaceutical-biologics-and-medical-device-industries-hardback-9780470552353","provider":"Freshly Printed Books","version":"1.0","type":"link"}