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Good laboratory practice regulations / edited by Sandy Weinberg.

Contributor(s): Weinberg, Sandy, 1950-.
Material type: TextTextSeries: Drugs and the pharmaceutical sciences ; v. 124. Publisher: New York : Marcel Dekker, 2003Edition: 3rd ed.Description: x, 244 p. ; 23 cm.ISBN: 0824708911 (alk. paper); 9780824708917.Subject(s): Medical laboratories -- Quality control | Pharmaceutical technologyDDC classification: 615.19 Online resources: Publisher description | E-book Fulltext
Contents:
Table of contents Historical Perspective, Jean M. Taylor and Gary C. SteinFDA/ GLP Regulations, Wendell A. PetersonApplying 21 CFR Part 11 to the Laboratory Environment, Sandy WeinbergThe Good Automated Laboratory Practices, Gerald J. Whartenby, Paul L. Robinson, and Sandy WeinbergImplementing GLP's in a Non-GLP Analytical Laboratory, Stephanie A. OlexaComputer Systems Validation, Sandy WeinbergThe FDA's GLP Inspection Program, George W. JamesThe Future, Sandy WeinbergBibliographyIndex
Summary: Summary: Covers all aspects of the Food and Drug Administration's (FDA), Good Laboratory Practice (GLP) regulations and techniques for implementation. This book details standards and general guidelines for the management of research environment. It examines theoretical principles for anticipating interpretations of GLP in a variety of laboratory settings
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Item type Current location Collection Call number Copy number Status Date due Barcode Item holds
E-Book E-Book EWU Library
E-book
Non-fiction 615.19 GOO 2003 (Browse shelf) Not for loan
Text Text EWU Library
Reserve Section
Non-fiction 615.19 GOO 2003 (Browse shelf) C-1 Not For Loan 17294
Text Text EWU Library
Reserve Section
Non-fiction 615.19 GOO 2003 (Browse shelf) C-2 Not For Loan 17326
Text Text EWU Library
Circulation Section
Non-fiction 615.19 GOO 2003 (Browse shelf) C-3 Available 18589
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Includes bibliographical references (p. 229-237) and index.

Table of contents Historical Perspective, Jean M. Taylor and Gary C. SteinFDA/ GLP Regulations, Wendell A. PetersonApplying 21 CFR Part 11 to the Laboratory Environment, Sandy WeinbergThe Good Automated Laboratory Practices, Gerald J. Whartenby, Paul L. Robinson, and Sandy WeinbergImplementing GLP's in a Non-GLP Analytical Laboratory, Stephanie A. OlexaComputer Systems Validation, Sandy WeinbergThe FDA's GLP Inspection Program, George W. JamesThe Future, Sandy WeinbergBibliographyIndex

Summary:
Covers all aspects of the Food and Drug Administration's (FDA), Good Laboratory Practice (GLP) regulations and techniques for implementation. This book details standards and general guidelines for the management of research environment. It examines theoretical principles for anticipating interpretations of GLP in a variety of laboratory settings

Pharmacy

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