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Cost-contained regulatory compliance

by Weinberg, Sandy,

Additional authors: ebrary, Inc.

Published by : John Wiley & Sons, (Hoboken, N.J. :) Physical details: ix, 284 p. : ill.

Subject(s): 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. | Electronic books.

Year: 2011

Online resources:

http://site.ebrary.com/lib/rucke/Doc?id=10452136
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Includes bibliographical references and index.

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.

Electronic reproduction. Palo Alto, Calif. : ebrary, 2011. Available via World Wide Web. Access may be limited to ebrary affiliated libraries.

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