000441235 000__ 02271nam\a2200517\a\4500 000441235 001__ 441235 000441235 003__ MiAaPQ 000441235 005__ 20211102003747.0 000441235 006__ m\\\\\o\\d\\\\\\\\ 000441235 007__ cr\cn\nnnunnun 000441235 008__ 100706s2011\\\\njua\\\\ob\\\\001\0\eng\d 000441235 010__ $$z 2010028410 000441235 020__ $$z9780470933510 000441235 020__ $$z9781118002278 000441235 020__ $$z9780470552353 (cloth) 000441235 020__ $$a9780470933503 (electronic bk.) 000441235 035__ $$a(MiAaPQ)EBC698933 000441235 035__ $$a(Au-PeEL)EBL698933 000441235 035__ $$a(CaPaEBR)ebr10452136 000441235 035__ $$a(CaONFJC)MIL302560 000441235 035__ $$a(OCoLC)706476143 000441235 040__ $$aMiAaPQ$$cMiAaPQ$$dMiAaPQ 000441235 043__ $$an-us--- 000441235 050_4 $$aHD9994.U52$$bW45 2011 000441235 08204 $$a615.1068/1$$222 000441235 1001_ $$aWeinberg, Sandy,$$d1950- 000441235 24510 $$aCost-contained regulatory compliance:$$bfor the pharmaceutical, biologics, and medical device industries /$$cSandy Weinberg. 000441235 260__ $$aHoboken, N.J. :$$bJohn Wiley & Sons,$$cc2011. 000441235 300__ $$aix, 284 p. :$$bill. 000441235 336__ $$atext$$2rdacontent 000441235 337__ $$acomputer$$2rdamedia 000441235 338__ $$aonline resource$$2rdacarrier 000441235 504__ $$aIncludes bibliographical references and index. 000441235 5050_ $$aControlling 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. 000441235 506__ $$aAccess limited to authorized users. 000441235 61010 $$aUnited States.$$bFood and Drug Administration. 000441235 650_0 $$aMedical instruments and apparatus industry$$zUnited States$$xCost control. 000441235 650_0 $$aMedical instruments and apparatus$$xInspection$$zUnited States. 000441235 650_0 $$aPharmaceutical industry$$zUnited States$$xCost control. 000441235 650_0 $$aPharmaceutical industry$$xInspection$$zUnited States. 000441235 655_0 $$aElectronic books 000441235 852__ $$bebk 000441235 85640 $$3ProQuest Ebook Central Academic Complete $$uhttps://univsouthin.idm.oclc.org/login?url=https://ebookcentral.proquest.com/lib/usiricelib-ebooks/detail.action?docID=698933$$zOnline Access 000441235 909CO $$ooai:library.usi.edu:441235$$pGLOBAL_SET 000441235 980__ $$aBIB 000441235 980__ $$aEBOOK 000441235 982__ $$aEbook 000441235 983__ $$aOnline