Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volumes 1, 2 & 3 (single user digital version)

Published
Jan 2015
Pages
714
PDA Item Number
17981
Format
PDF Single user
Member Price
$508.00
Nonmember Price
$632.00
Government Price
$348.00

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The three volumes Cleaning Validation: Practical Solutions for Pharmaceutical Manufacturing by Destin LeBlanc contains a complete, modified and updated collection of his Cleaning Memos. Volume 1 originally published from 2000-2004, Volume 2 published from January 2005 through December 2008 and Volume 3 published from January 2009 through December 2012. In all volumes, each Cleaning Memo is presented as a chapter, with the chapters then organized by common topics rather than chronologically. The benefit to having three volumes at hand, aside from gaining full insight into twelve years of subject-matter expert advice, is its accessibility by common subject.

Volume 1: 2006. ISBN: 1-933722-01-0.
Volume 2: 2010. ISBN: 1-933722-40-1.
Volume 3: 2013. ISBN: 1-933722-68-1.

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 4.54 MB)


 
Hardcover
Digital
Bundle Vol. 1, 2 & 3
Volume 1
N/A
Volume 2
Volume 3
Volume 4
N/A

Table of Contents

Table of Contents:

  • General Topics
  • Special Situations
  • Residue Limits
  • Analytical Methods
  • Sampling
  • Sampling Recovery
  • Protocol Issues
  • Grouping Strategies
  • Regulatory Issues
  • Microbial Issues
  • Visually Clean Issues
  • Validation Maintenance
  • Index

    Volume 1
    Click here to download>>>Detailed Table of Contents

    Volume 2
    Click here to download>>>Detailed Table of Contents

    Volume 3
    Click here to download>>>Detailed Table of Contents

  • About the Authors

    About the Author

    Destin A. LeBlanc consults in the area of cleaning validation at Cleaning Validation Technologies. He has extensive experience in product development and technical service for cleaning and antimicrobial applications. He has lectured on issues related to contamination control internationally, and has written widely on cleaning validation issues. He is the author of Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 2, and Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing. He regularly trains FDA personnel on cleaning validation. He is a graduate of the University of Michigan and the University of Iowa.