Cost-contained regulatory compliance [electronic resource] : for the pharmaceutical, biologics, and medical device industries / Sandy Weinberg.

By: Contributor(s): Material type: TextTextPublication details: Hoboken, N.J. : John Wiley & Sons, c2011.Description: ix, 284 p. : illSubject(s): Genre/Form: DDC classification:
  • 615.1068/1 22
LOC classification:
  • HD9994.U52 W45 2011eb
Online resources:
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.
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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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