Good Laboratory Practice Regulations Third Edition Revised And Expanded
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Author |
: Sandy Weinberg |
Publisher |
: CRC Press |
Total Pages |
: 256 |
Release |
: 2002-11-06 |
ISBN-10 |
: 9780824745646 |
ISBN-13 |
: 0824745647 |
Rating |
: 4/5 (46 Downloads) |
Synopsis Good Laboratory Practice Regulations, Third Edition, Revised and Expanded by : Sandy Weinberg
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general guidelines for the management of efficient and effective research environment. A guide to the current standards and requirements of good laboratory management, the book examines essential theoretical principles for anticipating new and emerging interpretations of GLP in a variety of laboratory settings.
Author |
: Sandy Weinberg |
Publisher |
: CRC Press |
Total Pages |
: 249 |
Release |
: 2002-11-06 |
ISBN-10 |
: 9780203911082 |
ISBN-13 |
: 0203911083 |
Rating |
: 4/5 (82 Downloads) |
Synopsis Good Laboratory Practice Regulations, Revised and Expanded by : Sandy Weinberg
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general g
Author |
: Sandy Weinberg |
Publisher |
: CRC Press |
Total Pages |
: 264 |
Release |
: 2002-11-06 |
ISBN-10 |
: 1135552509 |
ISBN-13 |
: 9781135552503 |
Rating |
: 4/5 (09 Downloads) |
Synopsis Good Laboratory Practice Regulations, Third Edition, Revised and Expanded by : Sandy Weinberg
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general guidelines for the management of efficient and effective research environment. A guide to the current standards and requirements of good laboratory management, the book examines essential theoretical principles for anticipating new and emerging interpretations of GLP in a variety of laboratory settings.
Author |
: Sandy Weinberg |
Publisher |
: CRC Press |
Total Pages |
: 320 |
Release |
: 1995 |
ISBN-10 |
: STANFORD:36105012419888 |
ISBN-13 |
: |
Rating |
: 4/5 (88 Downloads) |
Synopsis Good Laboratory Practice Regulations by : Sandy Weinberg
This work covers all aspects of the Food and Drug Administration's Good Laboratory Practice relgulations and techniques for implementation. This edition includes general knowledge on computer system validation, details on implementing GIPs in an automated laboratory, a forecast of the flexibility and effectiveness of GLPs in the changing laboratory environment, and a contemporary bibliography with new references.
Author |
: Sandy Weinberg |
Publisher |
: CRC Press |
Total Pages |
: 0 |
Release |
: 2007-01-19 |
ISBN-10 |
: 0849375835 |
ISBN-13 |
: 9780849375835 |
Rating |
: 4/5 (35 Downloads) |
Synopsis Good Laboratory Practice Regulations, Fourth Edition by : Sandy Weinberg
Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings. This updated and expanded classic text contains new information about applying 21 CFR Part 11 to the laboratory environment, GLP documentation systems, laboratory risk analysis, system validation and inspection, process analytical technologies, and cost control for the prevention of pitfalls and the assurance of compliance in numerous research environments. Providing insights for the application of GLP regulations and emphasizing the latest regulatory developments, this reference discusses the implementation of PAT and emphasizes the importance of electronic audit trails and data controls as laboratories rely more on automated procedures...gives clear rules for the acceptance of electronic signatures, archiving of data in formats accessible by electronic recovery and human retrieval, and the security of electronic documents...and details the FDA’s GLP inspection program.
Author |
: Sandy Weinberg |
Publisher |
: CRC Press |
Total Pages |
: 306 |
Release |
: 2007-01-19 |
ISBN-10 |
: 9780849375842 |
ISBN-13 |
: 0849375843 |
Rating |
: 4/5 (42 Downloads) |
Synopsis Good Laboratory Practice Regulations by : Sandy Weinberg
Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresse
Author |
: Anne Marie Dixon |
Publisher |
: CRC Press |
Total Pages |
: 254 |
Release |
: 2016-04-19 |
ISBN-10 |
: 9781420014853 |
ISBN-13 |
: 1420014854 |
Rating |
: 4/5 (53 Downloads) |
Synopsis Environmental Monitoring for Cleanrooms and Controlled Environments by : Anne Marie Dixon
A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments. In response
Author |
: Kevin L. Williams |
Publisher |
: CRC Press |
Total Pages |
: 441 |
Release |
: 2007-02-23 |
ISBN-10 |
: 9781420020595 |
ISBN-13 |
: 1420020595 |
Rating |
: 4/5 (95 Downloads) |
Synopsis Endotoxins by : Kevin L. Williams
This source expertly examines the discovery, biological structure, control, and continued clarification of endotoxin from a parenteral manufacturing perspective, with in-depth discussion of state-of-the-art technologies involving Limulus amebocyte lysate (LAL) such as assay development, automation, depyrogenation. Completely revised and exp
Author |
: David J. Hauss |
Publisher |
: CRC Press |
Total Pages |
: 370 |
Release |
: 2007-06-08 |
ISBN-10 |
: 9781420017267 |
ISBN-13 |
: 1420017268 |
Rating |
: 4/5 (67 Downloads) |
Synopsis Oral Lipid-Based Formulations by : David J. Hauss
Oral lipid-based formulations are attracting considerable attention due to their capacity to facilitate gastrointestinal absorption and reduce or eliminate the effect of food on the absorption of poorly water-soluble, lipophilic drugs. Despite the obvious and demonstrated utility of these formulations for addressing a persistent and growing problem
Author |
: Joseph T. Piechocki |
Publisher |
: CRC Press |
Total Pages |
: 445 |
Release |
: 2006-09-18 |
ISBN-10 |
: 9781420014136 |
ISBN-13 |
: 1420014137 |
Rating |
: 4/5 (36 Downloads) |
Synopsis Pharmaceutical Photostability and Stabilization Technology by : Joseph T. Piechocki
Based on a training course developed by Dr. Joseph T. Piechocki and other experts in this field whose contributions appear in this book for two International Meetings on the Photostability of Drugs and Drug Products, this text clarifies the guidelines set by the International Conference on Harmonization (ICH) and provides a comprehensive background