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02144nam a2200445 a 4500 |
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EBC698933 |
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MiAaPQ |
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20200520144314.0 |
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m o d | |
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100706s2011 njua sb 001 0 eng d |
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|z 2010028410
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|z 9780470933510
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|z 9781118002278
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|z 9780470552353 (cloth)
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|a 9780470933503 (electronic bk.)
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|a (MiAaPQ)EBC698933
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|a (Au-PeEL)EBL698933
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|a (CaPaEBR)ebr10452136
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|a (CaONFJC)MIL302560
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|a (OCoLC)706476143
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|a MiAaPQ
|c MiAaPQ
|d MiAaPQ
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|a n-us---
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|a HD9994.U52
|b W45 2011
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082 |
0 |
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|a 615.1068/1
|2 22
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100 |
1 |
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|a Weinberg, Sandy,
|d 1950-
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245 |
1 |
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|a Cost-contained regulatory compliance
|h [electronic resource] :
|b for the pharmaceutical, biologics, and medical device industries /
|c Sandy Weinberg.
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260 |
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|a Hoboken, N.J. :
|b John Wiley & Sons,
|c c2011.
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300 |
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|a ix, 284 p. :
|b ill.
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504 |
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|a Includes bibliographical references and index.
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505 |
0 |
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|a 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.
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533 |
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|a Electronic reproduction. Ann Arbor, MI : ProQuest, 2015. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries.
|
610 |
1 |
0 |
|a United States.
|b Food and Drug Administration.
|
650 |
|
0 |
|a Medical instruments and apparatus industry
|z United States
|x Cost control.
|
650 |
|
0 |
|a Medical instruments and apparatus
|x Inspection
|z United States.
|
650 |
|
0 |
|a Pharmaceutical industry
|z United States
|x Cost control.
|
650 |
|
0 |
|a Pharmaceutical industry
|x Inspection
|z United States.
|
655 |
|
4 |
|a Electronic books.
|
710 |
2 |
|
|a ProQuest (Firm)
|
856 |
4 |
0 |
|u https://ebookcentral.proquest.com/lib/matrademy/detail.action?docID=698933
|z Click to View
|