MARC details
| 000 -LEADER |
|---|
| fixed length control field |
02039nam a2200397 a 4500 |
| 001 - CONTROL NUMBER |
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| control field |
ebr10452136 |
| 003 - CONTROL NUMBER IDENTIFIER |
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| control field |
CaPaEBR |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS |
|---|
| fixed length control field |
m u |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
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| fixed length control field |
cr cn||||||||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
100706s2011 njua sb 001 0 eng d |
| 010 ## - LIBRARY OF CONGRESS CONTROL NUMBER |
|---|
| Canceled/invalid LC control number |
2010028410 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| Canceled/invalid ISBN |
9780470933510 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| Canceled/invalid ISBN |
9781118002278 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| Canceled/invalid ISBN |
9780470933503 (e-book) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| Canceled/invalid ISBN |
9780470552353 (cloth) |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
CaPaEBR |
| Transcribing agency |
CaPaEBR |
| 035 ## - SYSTEM CONTROL NUMBER |
|---|
| System control number |
(OCoLC)706476143 |
| 043 ## - GEOGRAPHIC AREA CODE |
|---|
| Geographic area code |
n-us--- |
| 050 14 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
HD9994.U52 |
| Item number |
W45 2011eb |
| 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 |
| Medium |
[electronic resource] : |
| 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. |
c2011. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
ix, 284 p. : |
| Other physical details |
ill. |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc |
Includes bibliographical references 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. |
| 533 ## - REPRODUCTION NOTE |
|---|
| Type of reproduction |
Electronic reproduction. |
| Place of reproduction |
Palo Alto, Calif. : |
| Agency responsible for reproduction |
ebrary, |
| Date of reproduction |
2011. |
| Note about reproduction |
Available via World Wide Web. |
| -- |
Access may be limited to ebrary affiliated libraries. |
| 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. |
| 655 #7 - INDEX TERM--GENRE/FORM |
|---|
| Genre/form data or focus term |
Electronic books. |
| Source of term |
local |
| 710 2# - ADDED ENTRY--CORPORATE NAME |
|---|
| Corporate name or jurisdiction name as entry element |
ebrary, Inc. |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Uniform Resource Identifier |
<a href="http://site.ebrary.com/lib/welingkar/Doc?id=10452136">http://site.ebrary.com/lib/welingkar/Doc?id=10452136</a> |
| Public note |
An electronic book accessible through the World Wide Web; click to view |
