Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 1 (single user digital version)

May 2017
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PDF Single user
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Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing by Destin LeBlanc contains a complete, modified and updated collection of his Cleaning Memos from 2000 through 2004, all organized by topic rather than chronologically. The only memo not included dealt with cleaning validation for medical devices, a subject not covered in this book, which focuses on the pharmaceutical industry. The clear benefit to having this information at hand, aside from gaining full insight into five years of subject-matter expert advice, is its accessibility by common subject.

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Format: PDF (1 file 1.69 MB)

Winner, 2006 PDA/DHI Technical Book Distinguished Editor/Author Award

"This book is dedicated to those who labor in the `vineyards` of process equipment cleaning validation in the pharmaceutical industry. I have benefited from your experience and from your questions, I hope that much of that knowledge is passed on in various chapters of this book."

Destin A. LeBlanc
Kodak, TN

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Book wrote in 2006.

Bundle Vol. 1, 2 & 3
Volume 1
Volume 2
Volume 3
Volume 4

Table of Contents

Table of Contents:
Click here to download >>> Detailed Table of Contents

General Topics (Click here to download >>>Chapter 1
Special Situations
Residue Limits
Analytical Methods
Sampling Recovery
Protocol Issues
Grouping Strategies
Regulatory Issues
Microbial Issues
Visually Clean Issues
Validation Maintenance

About the Authors

About the Author

Destin LeBlanc is a consultant at Cleaning Validation Technologies. He has extensive experience in product development and technical services for cleaning and antimicrobial applications. He is an international lecturer on contamination control and has written widely on cleaning validation topics including four volumes in the Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing series published by PDA and DHI. He is a member of PDA and ISPE and trains FDA personnel on cleaning validation. He is a graduate of the University of Michigan and the University of Iowa.