03051nam 2200673 a 450 991082725230332120240514015054.01-118-00227-X1-283-02560-497866130256090-470-93350-X0-470-93351-8(CKB)3400000000000292(EBL)698933(OCoLC)706476143(SSID)ssj0000468053(PQKBManifestationID)12165230(PQKBTitleCode)TC0000468053(PQKBWorkID)10498016(PQKB)10846111(MiAaPQ)EBC698933(Au-PeEL)EBL698933(CaPaEBR)ebr10452136(CaONFJC)MIL302560(OCoLC)646388488(FINmELB)ELB179616(EXLCZ)99340000000000029220100706d2011 uy 0engur|n|---|||||txtccrCost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries /Sandy Weinberg1st ed.Hoboken, N.J. John Wiley & Sonsc20111 online resource (296 p.)Description based upon print version of record.0-470-55235-2 Includes bibliographical references 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.Medical instruments and apparatus industryUnited StatesCost controlMedical instruments and apparatusInspectionUnited StatesPharmaceutical industryUnited StatesCost controlPharmaceutical industryInspectionUnited StatesMedical instruments and apparatus industryCost control.Medical instruments and apparatusInspectionPharmaceutical industryCost control.Pharmaceutical industryInspection615.1068/1Weinberg Sandy1950-1649779MiAaPQMiAaPQMiAaPQBOOK9910827252303321Cost-contained regulatory compliance4126783UNINA