Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries / (Record no. 204953)
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000 -LEADER | |
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fixed length control field | 04811cam a2201009Ka 4500 |
001 - CONTROL NUMBER | |
control field | ocn706476143 |
003 - CONTROL NUMBER IDENTIFIER | |
control field | OCoLC |
005 - DATE AND TIME OF LATEST TRANSACTION | |
control field | 20171119093245.0 |
006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
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 |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
International Standard Book Number | 9780470933503 |
Qualifying information | (electronic bk.) |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
International Standard Book Number | 047093350X |
Qualifying information | (electronic bk.) |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
International Standard Book Number | 9780470933510 |
Qualifying information | (electronic bk.) |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
International Standard Book Number | 0470933518 |
Qualifying information | (electronic bk.) |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
International Standard Book Number | 9781118002278 |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
International Standard Book Number | 111800227X |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
International Standard Book Number | 1283025604 |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
International Standard Book Number | 9781283025607 |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
Canceled/invalid ISBN | 9780470552353 |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
Canceled/invalid ISBN | 0470552352 |
024 8# - OTHER STANDARD IDENTIFIER | |
Standard number or code | 9786613025609 |
029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC) | |
OCLC library identifier | AU@ |
System control number | 000048832470 |
029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC) | |
OCLC library identifier | AU@ |
System control number | 000051561235 |
029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC) | |
OCLC library identifier | CHBIS |
System control number | 007307088 |
029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC) | |
OCLC library identifier | CHVBK |
System control number | 182704955 |
029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC) | |
OCLC library identifier | DEBBG |
System control number | BV041908365 |
029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC) | |
OCLC library identifier | DEBBG |
System control number | BV043086030 |
029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC) | |
OCLC library identifier | DEBSZ |
System control number | 372729282 |
029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC) | |
OCLC library identifier | DEBSZ |
System control number | 421628502 |
029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC) | |
OCLC library identifier | DEBSZ |
System control number | 430994788 |
029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC) | |
OCLC library identifier | DEBSZ |
System control number | 449243265 |
029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC) | |
OCLC library identifier | DKDLA |
System control number | 820120-katalog:000558042 |
029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC) | |
OCLC library identifier | HEBIS |
System control number | 29982053X |
029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC) | |
OCLC library identifier | NZ1 |
System control number | 14256077 |
029 1# - OTHER SYSTEM CONTROL NUMBER (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 |
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 |
043 ## - GEOGRAPHIC AREA CODE | |
Geographic area code | n-us--- |
049 ## - LOCAL HOLDINGS (OCLC) | |
Holding library | MAIN |
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 |
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 : for the pharmaceutical, biologics, and medical device industries / |
Statement of responsibility, etc. | Sandy Weinberg. |
Medium | [electronic resource] |
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 ## - CONTENT TYPE | |
Content type term | text |
Content type code | txt |
Source | rdacontent |
337 ## - MEDIA TYPE | |
Media type term | computer |
Media type code | c |
Source | rdamedia |
338 ## - CARRIER TYPE | |
Carrier type term | online resource |
Carrier type code | cr |
Source | rdacarrier |
347 ## - DIGITAL FILE CHARACTERISTICS | |
File type | data file |
Source | rda |
380 ## - FORM OF WORK | |
Form of work | 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# - SOURCE OF DESCRIPTION NOTE | |
Source of description note | Print version record. |
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 | |
Relationship information | 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 | http://onlinelibrary.wiley.com/book/10.1002/9780470933510 |
Public note | Wiley Online Library |
942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
Source of classification or shelving scheme | |
Koha item type | Books |
No items available.