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020 _a9781118002278
020 _a111800227X
020 _a1283025604
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020 _z9780470552353
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035 _a(OCoLC)706476143
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037 _a10.1002/9780470933510
_bWiley InterScience
_nhttp://www3.interscience.wiley.com
043 _an-us---
050 4 _aHD9994.U52
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072 7 _aMED
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082 0 4 _a615.1068/1
_222
049 _aMAIN
100 1 _aWeinberg, Sandy,
_d1950-
245 1 0 _aCost-contained regulatory compliance :
_bfor the pharmaceutical, biologics, and medical device industries /
_cSandy Weinberg.
260 _aHoboken, N.J. :
_bJohn Wiley & Sons,
_c©2011.
300 _a1 online resource (284 pages)
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _adata file
_2rda
380 _aBibliography
504 _aIncludes bibliographical references (pages 273-277) and index.
505 0 _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.
520 _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.
588 0 _aPrint version record.
610 1 0 _aUnited States.
_bFood and Drug Administration.
650 0 _aMedical instruments and apparatus industry
_zUnited States
_xCost control.
650 0 _aMedical instruments and apparatus
_xInspection
_zUnited States.
650 0 _aPharmaceutical industry
_zUnited States
_xCost control.
650 0 _aPharmaceutical industry
_xInspection
_zUnited States.
650 4 _aUnited States. Food and Drug Administration.
650 4 _aPharmacy.
650 4 _aBusiness.
650 4 _aMedicine.
650 7 _aMEDICAL
_xDrug Guides.
_2bisacsh
650 7 _aMEDICAL
_xPharmacology.
_2bisacsh
650 7 _aMEDICAL
_xPharmacy.
_2bisacsh
650 7 _aMEDICAL
_xNursing
_xPharmacology.
_2bisacsh
650 2 _aDrug Industry
_xeconomics
_zUnited States.
650 2 _aBiotechnology
_xeconomics
_zUnited States.
650 2 _aConsumer Product Safety
_xstandards
_zUnited States.
650 2 _aCost Control
_xmethods
_zUnited States.
650 2 _aEquipment and Supplies
_xeconomics
_zUnited States.
650 2 _aQuality Assurance, Health Care
_xeconomics
_zUnited States.
655 4 _aElectronic books.
776 0 8 _iPrint version:
_aWeinberg, Sandy, 1950-
_tCost-contained regulatory compliance.
_dHoboken, N.J. : John Wiley & Sons, ©2011
_z9780470552353
_w(DLC) 2010028410
_w(OCoLC)646388488
856 4 0 _uhttp://onlinelibrary.wiley.com/book/10.1002/9780470933510
_zWiley Online Library
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