Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries / / Sandy Weinberg.
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| Year of Publication: | 2011 |
| Language: | English |
| Online Access: | |
| Physical Description: | ix, 284 p. :; ill. |
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| 001 | 500698933 | ||
| 003 | MiAaPQ | ||
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| 006 | m o d | | ||
| 007 | cr cn||||||||| | ||
| 008 | 100706s2011 njua sb 001 0 eng d | ||
| 010 | |z 2010028410 | ||
| 020 | |z 9780470933510 | ||
| 020 | |z 9781118002278 | ||
| 020 | |z 9780470552353 (cloth) | ||
| 020 | |a 9780470933503 (electronic bk.) | ||
| 035 | |a (MiAaPQ)500698933 | ||
| 035 | |a (Au-PeEL)EBL698933 | ||
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| 040 | |a MiAaPQ |c MiAaPQ |d MiAaPQ | ||
| 043 | |a n-us--- | ||
| 050 | 4 | |a HD9994.U52 |b W45 2011 | |
| 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. 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/oeawat/detail.action?docID=698933 |z Click to View |