Weinberg, Sandy 1950- creator text bibliography Electronic books. nju Hoboken, N.J John Wiley & Sons ©2011 2011 monographic eng

electronic resource

1 online resource (284 pages) 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. 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. Sandy Weinberg. Includes bibliographical references (pages 273-277) and index. n-us--- 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 HD9994.U52 W45 2011eb 615.1068/1 QV 736 Weinberg, Sandy, 1950- Hoboken, N.J. : John Wiley & Sons, ©2011 (DLC) 2010028410 (OCoLC)646388488 9780470933503 047093350X 9780470933510 0470933518 9781118002278 111800227X 1283025604 9781283025607 10.1002/9780470933510 Wiley InterScience http://onlinelibrary.wiley.com/book/10.1002/9780470933510 http://onlinelibrary.wiley.com/book/10.1002/9780470933510 N$T 110309 20171119093245.0 ocn706476143 eng