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Data Integrity in the Pharmaceutical Industry

Data Integrity in the Pharmaceutical Industry


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About the Book

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.


About the Author:

Sarah Tanksley is a pharmaceutical quality and compliance consultant who has worked extensively on detecting and remediating data integrity issues in the pharmaceutical industry.

Prior to consulting, Ms. Tanksley served with the Food and Drug Administration as a Consumer Safety Officer for the Office of Compliance, Center for Biologic Evaluation and Research, where she reviewed new applications for approval and conducted inspections of pharmaceutical facilities. She has a strong background in laboratory science, having spent nearly seven years as a biologist in the Laboratory of Immunology at the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

Ms. Tanksley holds a B.S. in Biology from the College of William and Mary, an M.S. in Biochemistry and Molecular Biology from Georgetown University, and an M.S. in Regulatory Science from Johns Hopkins University. She is currently an adjunct professor at Georgetown University School of Medicine, where she teaches courses in Regulatory Affairs and GMP compliance to graduate students.


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Product Details
  • ISBN-13: 9781138731936
  • Publisher: CRC Press
  • Publisher Imprint: Crc Press
  • Height: 235 mm
  • No of Pages: 550
  • Spine Width: 0 mm
  • Width: 156 mm
  • ISBN-10: 1138731935
  • Publisher Date: 01 Jan 2021
  • Binding: Hardback
  • Language: English
  • Returnable: N
  • Weight: 160 gr


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