Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries - Weinberg, Sandy, 1950- (Hoboken, N.J. : John Wiley & Sons, 2011)
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.
Includes bibliographical references and index.
Description based on metadata supplied by the publisher and other sources.
Electronic reproduction. Santa Fe, Arg.: elibro, 2022. Available via World Wide Web. Access may be limited to eLibro affiliated libraries.
Keywords: 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