Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries /

• Κύριος συγγραφέας: Weinberg, Sandy, 1950-
• Μορφή: Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Hoboken, N.J. : John Wiley & Sons, [2011]
• Θέματα: United States. > Food and Drug Administration.; Medical instruments and apparatus industry > United States > Cost control.; Medical instruments and apparatus > Inspection > United States.; Pharmaceutical industry > United States > Cost control.; Pharmaceutical industry > Inspection > United States.; United States. Food and Drug Administration.; Pharmacy.; Business.; Medicine.; MEDICAL > Drug Guides.; MEDICAL > Pharmacology.; MEDICAL > Pharmacy.; MEDICAL > Nursing > Pharmacology.; Drug Industry > economics > United States.; Biotechnology > economics > United States.; Consumer Product Safety > standards > United States.; Cost Control > methods > United States.; Equipment and Supplies > economics > United States.; Quality Assurance, Health Care > economics > United States.; Electronic books.

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...

Πίνακας περιεχομένων:

• Controlling regulatory costs
• Clear operation definitions of requirements
• Pre-regulatory audits
• Quality by design
• Outsourcing
• Electronic submissions
• Emea/fda coordination
• Managing FDA inspections
• Risk assessment
• Cases
• Cost containment analysis
• Managing regulation in times of chaos
• International regulation
• Cost contained regulatory compliance.