000			02039nam a2200397 a 4500
001			ebr10452136
003			CaPaEBR
006			m u
007			cr cn|||||||||
008			100706s2011 njua sb 001 0 eng d
010			_z 2010028410
020			_z9780470933510
020			_z9781118002278
020			_z9780470933503 (e-book)
020			_z9780470552353 (cloth)
040			_aCaPaEBR _cCaPaEBR
035			_a(OCoLC)706476143
043			_an-us---
050	1	4	_aHD9994.U52 _bW45 2011eb
082	0	4	_a615.1068/1 _222
100	1		_aWeinberg, Sandy, _d1950-
245	1	0	_aCost-contained regulatory compliance _h[electronic resource] : _bfor the pharmaceutical, biologics, and medical device industries / _cSandy Weinberg.
260			_aHoboken, N.J. : _bJohn Wiley & Sons, _cc2011.
300			_aix, 284 p. : _bill.
504			_aIncludes bibliographical references 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.
533			_aElectronic reproduction. _bPalo Alto, Calif. : _cebrary, _d2011. _nAvailable via World Wide Web. _nAccess may be limited to ebrary affiliated libraries.
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.
655		7	_aElectronic books. _2local
710	2		_aebrary, Inc.
856	4	0	_uhttp://site.ebrary.com/lib/welingkar/Doc?id=10452136 _zAn electronic book accessible through the World Wide Web; click to view
999			_c75217 _d75217