{"product_id":"regulatory-compliance-9780470552353","title":"Regulatory Compliance","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\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.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\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","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49402363183447,"sku":"9780470552353","price":90.86,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9780470552353.jpg?v=1730480176","url":"https:\/\/bookcurl.com\/products\/regulatory-compliance-9780470552353","provider":"Book Curl","version":"1.0","type":"link"}