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100706s2011 njua sb 001 0 eng d |
| 010 |
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|z 2010028410
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| 020 |
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|z 9780470933510
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| 020 |
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|z 9781118002278
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| 020 |
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|z 9780470552353 (cloth)
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| 020 |
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|a 9780470933503 (electronic bk.)
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| 035 |
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|a (OCoLC)646388488
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|a FINmELB
|c FINmELB
|d FINmELB
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|a n-us---
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| 050 |
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4 |
|a HD9994.U52
|b W45 2011
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| 082 |
0 |
4 |
|a 615.1068/1
|2 22
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| 100 |
1 |
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|a Weinberg, Sandy,
|d 1950-
|
| 245 |
1 |
0 |
|a Cost-contained regulatory compliance
|h [electronic resource] :
|b for the pharmaceutical, biologics, and medical device industries /
|c Sandy Weinberg.
|
| 260 |
|
|
|a Hoboken, N.J. :
|b John Wiley & Sons,
|c c2011.
|
| 300 |
|
|
|a ix, 284 p. :
|b ill.
|
| 504 |
|
|
|a Includes bibliographical references and index.
|
| 505 |
0 |
|
|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.
|
| 588 |
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|a Description based on metadata supplied by the publisher and other sources.
|
| 590 |
|
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|a Electronic reproduction. Santa Fe, Arg.: elibro, 2022. Available via World Wide Web. Access may be limited to eLibro 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.
|
| 797 |
2 |
|
|a elibro, Corp.
|
| 856 |
4 |
0 |
|u https://elibro.uam.elogim.com/ereader/bidiuam/179616
|z Texto completo
|
| 950 |
|
|
|a eLibro English
|
