| 000 | 04811cam a2201009Ka 4500 | ||
|---|---|---|---|
| 001 | ocn706476143 | ||
| 003 | OCoLC | ||
| 005 | 20171119093245.0 | ||
| 006 | m o d | ||
| 007 | cr cnu---unuuu | ||
| 008 | 110309s2011 nju ob 001 0 eng d | ||
| 010 | _z 2010028410 | ||
| 020 |
_a9780470933503 _q(electronic bk.) |
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_a9780470933510 _q(electronic bk.) |
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_a0470933518 _q(electronic bk.) |
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| 020 | _a9781118002278 | ||
| 020 | _a111800227X | ||
| 020 | _a1283025604 | ||
| 020 | _a9781283025607 | ||
| 020 | _z9780470552353 | ||
| 020 | _z0470552352 | ||
| 024 | 8 | _a9786613025609 | |
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_a(OCoLC)706476143 _z(OCoLC)711780339 _z(OCoLC)716206102 _z(OCoLC)723440217 _z(OCoLC)741259099 _z(OCoLC)781410801 _z(OCoLC)816649045 _z(OCoLC)961492064 _z(OCoLC)962605728 |
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| 037 |
_a10.1002/9780470933510 _bWiley InterScience _nhttp://www3.interscience.wiley.com |
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| 040 |
_aN$T _beng _epn _cN$T _dDG1 _dE7B _dUIU _dCDX _dYDXCP _dEBLCP _dMHW _dOCLCQ _dDEBSZ _dOCLCQ _dOCLCA _dOCLCQ _dOCLCO _dIDEBK _dNLGGC _dOCLCQ _dCHVBK _dOCLCA _dAU@ _dUKDOC _dDEBBG _dOCLCQ _dD6H _dAZK |
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| 043 | _an-us--- | ||
| 049 | _aMAIN | ||
| 050 | 4 |
_aHD9994.U52 _bW45 2011eb |
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| 060 | 4 | _aQV 736 | |
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_aMED _x023000 _2bisacsh |
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| 082 | 0 | 4 |
_a615.1068/1 _222 |
| 100 | 1 |
_aWeinberg, Sandy, _d1950- |
|
| 245 | 1 | 0 |
_aCost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries / _cSandy Weinberg. _h[electronic resource] |
| 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 |
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| 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 |
| 942 |
_2ddc _cBK |
||
| 999 |
_c204953 _d204953 |
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