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

Weinberg, Sandy, 1950- (Author). ebrary, Inc. (Added Author).
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Electronic resources

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.

Record details

  • Physical Description: ix, 284 p. : ill.
  • Publisher: Hoboken, N.J. : John Wiley & Sons, c2011.

Content descriptions

Bibliography, etc. Note: Includes bibliographical references and index.
Formatted Contents Note: 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 Note: Electronic reproduction. Palo Alto, Calif. : ebrary, 2011. Available via World Wide Web. Access may be limited to ebrary affiliated libraries.
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