Cost-Contained Regulatory Compliance —— For the Pharmaceutical, Biologics, and Medical Device Industries

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ISBN: 9780470552353 出版年：2011 页码：296 Sandy Weinberg Wiley

PREFACE. Chapter 1. Controlling Regulatory Costs. Chapter 2. Clear Operation Definitions of Requirements. Chapter 3. Pre-Regulatory Audits. Chapter 4. Quality by Design. Chapter 5. Outsourcing. Chapter 6. Electronic Submissions. Chapter 7. EMEA/FDA Inspections. Chapter 8. Managing FDA Inspections. Chapter 9. Risk Assessment. Chapter 10. Cases. Chapter 11. Cost Containment Analysis. Chapter 12. Managing Regulation In Times of Chaos. Chapter 13. International Regulation. Chapter 14. Cost Contained Regulatory Compliance. Chapter 15. Future. BIBLIOGRAPHY. INDEX .