Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries /
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| Main Author: | |
|---|---|
| Corporate Author: | |
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Hoboken, N.J. :
John Wiley & Sons,
c2011.
|
| Subjects: | |
| Online Access: | An electronic book accessible through the World Wide Web; click to view |
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| 008 | 100706s2011 njua sb 001 0 eng d | ||
| 010 | |z 2010028410 | ||
| 020 | |z 9780470933510 | ||
| 020 | |z 9781118002278 | ||
| 020 | |z 9780470933503 (e-book) | ||
| 020 | |z 9780470552353 (cloth) | ||
| 035 | |a (CaPaEBR)ebr10452136 | ||
| 035 | |a (OCoLC)706476143 | ||
| 040 | |a CaPaEBR |c CaPaEBR | ||
| 043 | |a n-us--- | ||
| 050 | 1 | 4 | |a HD9994.U52 |b W45 2011eb |
| 082 | 0 | 4 | |a 615.1068/1 |2 22 |
| 100 | 1 | |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. | |
| 533 | |a Electronic reproduction. |b Palo Alto, Calif. : |c ebrary, |d 2011. |n Available via World Wide Web. |n Access may be limited to ebrary 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 | 7 | |a Electronic books. |2 local | |
| 710 | 2 | |a ebrary, Inc. | |
| 856 | 4 | 0 | |u http://site.ebrary.com/lib/daystar/Doc?id=10452136 |z An electronic book accessible through the World Wide Web; click to view |
| 908 | |a 170314 | ||
| 942 | 0 | 0 | |c EB |
| 999 | |c 120433 |d 120433 | ||
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