Cost-contained regulatory compliance [electronic resource] : for the pharmaceutical, biologics, and medical device industries / Sandy Weinberg.
Material type: TextPublication details: Hoboken, N.J. : John Wiley & Sons, c2011.Description: ix, 284 p. : illSubject(s): Genre/Form: DDC classification:- 615.1068/1 22
- HD9994.U52 W45 2011
Item type | Current library | Call number | Status | Date due | Barcode | |
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Ebook | TUS: Midlands, Main Library Athlone Online | eBook (Browse shelf(Opens below)) | Available |
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.