Cost-contained regulatory compliance: for the pharmaceutical, biologics, and medical device industries / Sandy Weinberg.
2011
HD9994.U52 W45 2011
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Details
Title
Cost-contained regulatory compliance: for the pharmaceutical, biologics, and medical device industries / Sandy Weinberg.
Author
Weinberg, Sandy, 1950-
ISBN
9780470933510
9781118002278
9780470552353 (cloth)
9780470933503 (electronic bk.)
9781118002278
9780470552353 (cloth)
9780470933503 (electronic bk.)
Publication Details
Hoboken, N.J. : John Wiley & Sons, c2011.
Language
English
Description
ix, 284 p. : ill.
Call Number
HD9994.U52 W45 2011
Dewey Decimal Classification
615.1068/1
Bibliography, etc. Note
Includes bibliographical references and index.
Access Note
Access limited to authorized users.
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Table of 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.
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.