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Author
Weinberg, Sandy, 1950-
Title
Cost-contained regulatory compliance [electronic resource] : for the pharmaceutical, biologics, and medical device industries / Sandy Weinberg.
Imprint
Hoboken, N.J. : John Wiley & Sons, c2011.
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Available to Pittsburg State University patrons only.
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Call No.
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Status
Axe ProQuest E-Book
Electronic Book
---
Available
Description
ix, 284 p. : ill.
Bibliography
Includes bibliographical references and index.
Contents
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.
Reproduction
Electronic reproduction. Ann Arbor, MI : ProQuest, 2015. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries.
Subject
United States. Food and Drug Administration.
Medical instruments and apparatus industry -- United States -- Cost control.
Medical instruments and apparatus -- Inspection -- United States.
Pharmaceutical industry -- United States -- Cost control.
Pharmaceutical industry -- Inspection -- United States.
Genre/Form
Electronic books.
Added Author
ProQuest (Firm)
ISBN
9780470933510
9781118002278
9780470552353 (cloth)
9780470933503 (electronic bk.)
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