04811cam a2201009Ka 4500 ocn706476143 OCoLC 20171119093245.0 m o d cr cnu---unuuu 110309s2011 nju ob 001 0 eng d 2010028410 9780470933503 (electronic bk.) 047093350X (electronic bk.) 9780470933510 (electronic bk.) 0470933518 (electronic bk.) 9781118002278 111800227X 1283025604 9781283025607 9780470552353 0470552352 9786613025609 AU@ 000048832470 AU@ 000051561235 CHBIS 007307088 CHVBK 182704955 DEBBG BV041908365 DEBBG BV043086030 DEBSZ 372729282 DEBSZ 421628502 DEBSZ 430994788 DEBSZ 449243265 DKDLA 820120-katalog:000558042 HEBIS 29982053X NZ1 14256077 DEBBG BV043392896 (OCoLC)706476143 (OCoLC)711780339 (OCoLC)716206102 (OCoLC)723440217 (OCoLC)741259099 (OCoLC)781410801 (OCoLC)816649045 (OCoLC)961492064 (OCoLC)962605728 10.1002/9780470933510 Wiley InterScience http://www3.interscience.wiley.com N$T eng pn N$T DG1 E7B UIU CDX YDXCP EBLCP MHW OCLCQ DEBSZ OCLCQ OCLCA OCLCQ OCLCO IDEBK NLGGC OCLCQ CHVBK OCLCA AU@ UKDOC DEBBG OCLCQ D6H AZK n-us--- MAIN HD9994.U52 W45 2011eb QV 736 MED 023000 bisacsh MED 071000 bisacsh MED 072000 bisacsh MED 058170 bisacsh MMG bicssc 615.1068/1 22 Weinberg, Sandy, 1950- Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries / Sandy Weinberg. [electronic resource] Hoboken, N.J. : John Wiley & Sons, ©2011. 1 online resource (284 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier data file rda Bibliography Includes bibliographical references (pages 273-277) and index. 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. 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. Print version record. 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. bisacsh MEDICAL Pharmacology. bisacsh MEDICAL Pharmacy. bisacsh MEDICAL Nursing Pharmacology. bisacsh 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. Print version: Weinberg, Sandy, 1950- Cost-contained regulatory compliance. Hoboken, N.J. : John Wiley & Sons, ©2011 9780470552353 (DLC) 2010028410 (OCoLC)646388488 http://onlinelibrary.wiley.com/book/10.1002/9780470933510 Wiley Online Library ddc BK 204953 204953