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.
• Φυσική περιγραφή: 1 online resource (284 pages)
• Βιβλιογραφία: Includes bibliographical references (pages 273-277) and index.
• ISBN: 9780470933503; 047093350X; 9780470933510; 0470933518; 9781118002278; 111800227X; 1283025604; 9781283025607
• DOI: 10.1002/9780470933510

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.