Thursday, 29 April 2021

Conducting Compliant Investigations


A new book of interest (edited by Jeanne Moldenhauer), covering different approaches to conducting compliant investigations, where compliant is defined as meeting the requirements of the applicable regulatory documents.

Conducting Compliant Investigations

The information it provides on conducting investigations that will be acceptable to regulatory investigators will be instrumental in helping you to significantly reduce regulatory risk.

Select topics covered in this book include:

  • Why should we perform investigations?
  • What should be determined in the investigation?
  • Detailed background on U.S. FDA 483 and U.S. FDA Warning Letters investigations
  • What types of regulatory actions are taken in response to failure investigations?
  • Chapters on investigating various types of failures (e.g., data integrity, sterility test, media fill, environmental monitoring)
  • Descriptions of appropriate corrective and preventative actions
  • Writing a good investigation report
  • Tracking and trending investigations

The book includes two chapter written by Tim Sandle:

  Sandle, T. (2021) Getting to the heart of the matter: Approaching root cause analysis. In Moldenhauer, J. (Ed.) Conducting Compliant Investigations, DHI/PDA, River Grove, IL, USA pp45-108 ISBN 978-942911-57-9

Sandle, T. (2021) Investigating sterility test failures. In Moldenhauer, J. (Ed.) Conducting Compliant Investigations, DHI/PDA, River Grove, IL, USA pp227-268 ISBN 978-942911-57-9

 

Conducting Compliant Invest... by Tim Sandle

For details, see the PDA Booksore: https://www.pda.org/bookstore/product-detail/6061-conducting-compliant-investigations

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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