Book Detail
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Medicine > Pharmacology
Data Integrity in the Pharmaceutical Industry: Current Topics and Effective Strategies
Tanksley, Sarah
ISBN 13: 
9781138731936
ISBN 10: 
1138731935
Category: 
Pharmacology
Edition: 
1
Publisher: 
Taylor & Francis
Publication Date: 
01/2021
Format: 
Cloth
Status: 
Not Yet Published
Imprint: 
CRC Press
Affiliation: 
Tanksley Consulting Group Inc.
Pages: 
550
Weight: 
2
Retail Price: 
169.95 (Tentative Price May Change)
Quantity On Hand: 
0
Quantity On Order: 
0
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Synopsis:

Many articles describe the history and theory behind data integrity. However, few offer practical advice and solutions. Written by an author with a vast amount of experience in the industry, Data Integrity in the Pharmaceutical Industry: Current Topics and Effective Strategies serves as a hands-on guide to the current regulatory expectations for generating and handling data. This unique text presents techniques for tracing the life cycle of data, as well as identification and avoidance of common blind spots in the data collection and review process, examples of lapses in data integrity, and strategies for remediation of data integrity breaches. It also discusses requirements and advice for communicating data integrity breaches to health authorities.

As international government bodies have shifted their point of interest to focus on data integrity as part of their routine operations, this book is a must read for anyone working in a GMP (good manufacturing practices) regulated environment, whether the job involves supporting, generating, reviewing, or archiving data.


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