Sandy Weinberg

Cost-Contained Regulatory Compliance (eBook, PDF)

For the Pharmaceutical, Biologics, and Medical Device Industries

• Format: PDF

Produktbeschreibung

This 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.

---

Dieser Download kann aus rechtlichen Gründen nur mit Rechnungsadresse in A, B, BG, CY, CZ, D, DK, EW, E, FIN, F, GR, HR, H, IRL, I, LT, L, LR, M, NL, PL, P, R, S, SLO, SK ausgeliefert werden.

Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 304
• Erscheinungstermin: 14. Februar 2011
• Englisch
• ISBN-13: 9780470933503
• Artikelnr.: 37300865

Autorenporträt

SANDY WEINBERG, PhD, is a professor of healthcare management at Clayton State University in Atlanta and an international regulatory consultant. He has thirty-five years' regulatory experience, including global executive responsibility at GE Healthcare and Tikvah Therapeutics. Dr. Weinberg has written thirteen books including, most recently, Guidebook for Drug Regulatory Submissions, also from Wiley.

Inhaltsangabe

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 .