Cost-contained regulatory compliance (Record no. 249974)

000 -LEADER
fixed length control field 02037nam a2200397 a 4500
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.1068/1
100 1# - MAIN ENTRY--AUTHOR NAME
Personal name Weinberg, Sandy,
245 10 - TITLE STATEMENT
Title Cost-contained regulatory compliance
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication Hoboken, N.J. :
Name of publisher John Wiley & Sons,
Year of publication c2011.
300 ## - PHYSICAL DESCRIPTION
Number of Pages ix, 284 p. :
Other physical details ill.
505 0# - FORMATTED CONTENTS NOTE
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.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical Term Medical instruments and apparatus industry
Topical Term Medical instruments and apparatus
Topical Term Pharmaceutical industry
Topical Term Pharmaceutical industry
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier http://site.ebrary.com/lib/rucke/Doc?id=10452136

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