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Weinberg, Sandy, 1950-

Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries / [electronic resource] : Sandy Weinberg. - Hoboken, N.J. : John Wiley & Sons, c2011. - ix, 284 p. : ill.

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. Ann Arbor, MI : ProQuest, 2015. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries.

ISBN:

LCCN:

Subjects--Corporate Names:
United States. Food and Drug Administration.

Subjects--Topical Terms:
Medical instruments and apparatus industry--Cost control.--United States
Medical instruments and apparatus--Inspection--United States.
Pharmaceutical industry--Cost control.--United States
Pharmaceutical industry--Inspection--United States.

Index Terms--Genre/Form:
Electronic books.

LC Class. No.: HD9994.U52 / W45 2011

Dewey Class. No.: 615.1068/1