Check nearby libraries
Buy this book
The first systematic, hands-on auditing guide for today's pharmaceutical laboratories In today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing a CGMP Laboratory Audit System: A Practical Guide is designed to provide laboratory supervisors and personnel with a step-by-step, hands-on audit system that they can rely on to ensure their facility remains compliant with all current and future requirements. Focusing on a "team approach," the author uses detailed flowcharts, checklists, and descriptions of the auditing process to help readers develop a new audit system or upgrade their current system in order to: Improve current compliance Demonstrate sustainable compliance Produce data for federal inspections Avoid regulatory action Enhanced with detailed checklists and a wealth of practical and flexible auditing tools on CD-ROM, this book provides an ideal resource for new and future laboratory personnel, and an excellent means for keeping existing industry practitioners up to date on the nuances of operating a consistently compliant pharmaceutical laboratory.Note: CD-ROM/DVD and other supplementary materials are not included.
Check nearby libraries
Buy this book
Previews available in: English
Edition | Availability |
---|---|
1
Establishing a CGMP Laboratory Audit System: A Practical Guide
2007, Wiley & Sons, Incorporated, John
in English
0470239387 9780470239384
|
zzzz
|
2
Establishing a Cgmp Laboratory Audit System
2006, Wiley & Sons Canada, Limited, John
in English
1280448083 9781280448089
|
zzzz
|
3
Establishing a CGMP Laboratory Audit System: A Practical Guide
2006, Wiley & Sons, Incorporated, John
in English
0471784788 9780471784784
|
zzzz
|
4
Establishing a CGMP laboratory audit system: a practical guide
2006, Wiley-Interscience
in English
0471738409 9780471738404
|
aaaa
|
5
Establishing A CGMP Laboratory Audit System
2006, John Wiley & Sons, Ltd.
Electronic resource
in English
047178477X 9780471784777
|
zzzz
|
Book Details
Table of Contents
Edition Notes
Includes bibliographical references and index.
Classifications
The Physical Object
ID Numbers
Community Reviews (0)
Feedback?December 11, 2020 | Edited by MARC Bot | import existing book |
August 20, 2020 | Edited by ImportBot | import existing book |
July 22, 2019 | Edited by MARC Bot | remove fake subjects |
July 29, 2014 | Edited by ImportBot | import new book |
December 10, 2009 | Created by WorkBot | add works page |