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100   $a20100706d2011      uy         0
101 0 $aeng
135   $aur|n|---|||||
181   $ctxt
182   $cc
183   $acr
200 10$aCost-contained regulatory compliance $efor the pharmaceutical, biologics, and medical device industries /$fSandy Weinberg
205   $a1st ed.
210   $aHoboken, N.J. $cJohn Wiley & Sons$dc2011
215   $a1 online resource (296 p.)
300   $aDescription based upon print version of record.
311   $a0-470-55235-2 
320   $aIncludes bibliographical references and index.
327   $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.
330   $aThis 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.
606   $aMedical instruments and apparatus industry$zUnited States$xCost control
606   $aMedical instruments and apparatus$xInspection$zUnited States
606   $aPharmaceutical industry$zUnited States$xCost control
606   $aPharmaceutical industry$xInspection$zUnited States
615  0$aMedical instruments and apparatus industry$xCost control.
615  0$aMedical instruments and apparatus$xInspection
615  0$aPharmaceutical industry$xCost control.
615  0$aPharmaceutical industry$xInspection
676   $a615.1068/1
700   $aWeinberg$b Sandy$f1950-$01649779
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910827252303321
996   $aCost-contained regulatory compliance$94126783
997   $aUNINA