Cost-contained regulatory compliance : (Record no. 18681)

MARC details
000 -LEADER
fixed length control field 04892cam a2201033Ka 4500
001 - CONTROL NUMBER
control field ocn706476143
003 - CONTROL NUMBER IDENTIFIER
control field OCoLC
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20230823095611.0
006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS--GENERAL INFORMATION
fixed length control field m o d
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
fixed length control field cr cnu---unuuu
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 110309s2011 nju ob 001 0 eng d
010 ## - LIBRARY OF CONGRESS CONTROL NUMBER
Canceled/invalid LC control number 2010028410
040 ## - CATALOGING SOURCE
Original cataloging agency N$T
Language of cataloging eng
Description conventions pn
Transcribing agency N$T
Modifying agency DG1
-- E7B
-- UIU
-- CDX
-- YDXCP
-- EBLCP
-- MHW
-- OCLCQ
-- DEBSZ
-- OCLCQ
-- OCLCA
-- OCLCQ
-- OCLCO
-- IDEBK
-- NLGGC
-- OCLCQ
-- CHVBK
-- OCLCA
-- AU@
-- UKDOC
-- DEBBG
-- OCLCQ
-- D6H
-- AZK
019 ## -
-- 711780339
-- 716206102
-- 723440217
-- 741259099
-- 781410801
-- 816649045
-- 961492064
-- 962605728
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 9780470933503
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 047093350X
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 9780470933510
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 0470933518
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 9781118002278
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 111800227X
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 1283025604
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 9781283025607
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Cancelled/invalid ISBN 9780470552353
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Cancelled/invalid ISBN 0470552352
024 8# - OTHER STANDARD IDENTIFIER
Standard number or code 9786613025609
029 1# - (OCLC)
OCLC library identifier AU@
System control number 000048832470
029 1# - (OCLC)
OCLC library identifier AU@
System control number 000051561235
029 1# - (OCLC)
OCLC library identifier CHBIS
System control number 007307088
029 1# - (OCLC)
OCLC library identifier CHVBK
System control number 182704955
029 1# - (OCLC)
OCLC library identifier DEBBG
System control number BV041908365
029 1# - (OCLC)
OCLC library identifier DEBBG
System control number BV043086030
029 1# - (OCLC)
OCLC library identifier DEBSZ
System control number 372729282
029 1# - (OCLC)
OCLC library identifier DEBSZ
System control number 421628502
029 1# - (OCLC)
OCLC library identifier DEBSZ
System control number 430994788
029 1# - (OCLC)
OCLC library identifier DEBSZ
System control number 449243265
029 1# - (OCLC)
OCLC library identifier DKDLA
System control number 820120-katalog:000558042
029 1# - (OCLC)
OCLC library identifier HEBIS
System control number 29982053X
029 1# - (OCLC)
OCLC library identifier NZ1
System control number 14256077
029 1# - (OCLC)
OCLC library identifier DEBBG
System control number BV043392896
035 ## - SYSTEM CONTROL NUMBER
System control number (OCoLC)706476143
Canceled/invalid control number (OCoLC)711780339
-- (OCoLC)716206102
-- (OCoLC)723440217
-- (OCoLC)741259099
-- (OCoLC)781410801
-- (OCoLC)816649045
-- (OCoLC)961492064
-- (OCoLC)962605728
037 ## - SOURCE OF ACQUISITION
Stock number 10.1002/9780470933510
Source of stock number/acquisition Wiley InterScience
Note http://www3.interscience.wiley.com
043 ## - GEOGRAPHIC AREA CODE
Geographic area code n-us---
050 #4 - LIBRARY OF CONGRESS CALL NUMBER
Classification number HD9994.U52
Item number W45 2011eb
060 #4 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER
Classification number QV 736
072 #7 - SUBJECT CATEGORY CODE
Subject category code MED
Subject category code subdivision 023000
Source bisacsh
072 #7 - SUBJECT CATEGORY CODE
Subject category code MED
Subject category code subdivision 071000
Source bisacsh
072 #7 - SUBJECT CATEGORY CODE
Subject category code MED
Subject category code subdivision 072000
Source bisacsh
072 #7 - SUBJECT CATEGORY CODE
Subject category code MED
Subject category code subdivision 058170
Source bisacsh
072 #7 - SUBJECT CATEGORY CODE
Subject category code MMG
Source bicssc
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.1068/1
Edition number 22
049 ## - LOCAL HOLDINGS (OCLC)
Holding library MAIN
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Weinberg, Sandy,
Dates associated with a name 1950-
245 10 - TITLE STATEMENT
Title Cost-contained regulatory compliance :
Remainder of title for the pharmaceutical, biologics, and medical device industries /
Statement of responsibility, etc Sandy Weinberg.
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication, distribution, etc Hoboken, N.J. :
Name of publisher, distributor, etc John Wiley & Sons,
Date of publication, distribution, etc ©2011.
300 ## - PHYSICAL DESCRIPTION
Extent 1 online resource (284 pages)
336 ## -
-- text
-- txt
-- rdacontent
337 ## -
-- computer
-- c
-- rdamedia
338 ## -
-- online resource
-- cr
-- rdacarrier
347 ## -
-- data file
-- rda
380 ## -
-- Bibliography
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc Includes bibliographical references (pages 273-277) and index.
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.
520 ## - SUMMARY, ETC.
Summary, etc This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.
588 0# -
-- Print version record.
526 ## - STUDY PROGRAM INFORMATION NOTE
Department Biotechnology & Bioinformatics
610 10 - SUBJECT ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element United States.
Subordinate unit Food and Drug Administration.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Medical instruments and apparatus industry
Geographic subdivision United States
General subdivision Cost control.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Medical instruments and apparatus
General subdivision Inspection
Geographic subdivision United States.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Pharmaceutical industry
Geographic subdivision United States
General subdivision Cost control.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Pharmaceutical industry
General subdivision Inspection
Geographic subdivision United States.
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element United States. Food and Drug Administration.
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Pharmacy.
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Business.
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Medicine.
650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element MEDICAL
General subdivision Drug Guides.
Source of heading or term bisacsh
650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element MEDICAL
General subdivision Pharmacology.
Source of heading or term bisacsh
650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element MEDICAL
General subdivision Pharmacy.
Source of heading or term bisacsh
650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element MEDICAL
General subdivision Nursing
-- Pharmacology.
Source of heading or term bisacsh
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drug Industry
General subdivision economics
Geographic subdivision United States.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Biotechnology
General subdivision economics
Geographic subdivision United States.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Consumer Product Safety
General subdivision standards
Geographic subdivision United States.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Cost Control
General subdivision methods
Geographic subdivision United States.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Equipment and Supplies
General subdivision economics
Geographic subdivision United States.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Quality Assurance, Health Care
General subdivision economics
Geographic subdivision United States.
655 #4 - INDEX TERM--GENRE/FORM
Genre/form data or focus term Electronic books.
776 08 - ADDITIONAL PHYSICAL FORM ENTRY
Display text Print version:
Main entry heading Weinberg, Sandy, 1950-
Title Cost-contained regulatory compliance.
Place, publisher, and date of publication Hoboken, N.J. : John Wiley & Sons, ©2011
International Standard Book Number 9780470552353
Record control number (DLC) 2010028410
-- (OCoLC)646388488
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier <a href="http://dx.doi.org/10.1002/9780470933510">http://dx.doi.org/10.1002/9780470933510</a>
Public note Wiley Online Library
994 ## -
-- 92
-- DG1

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