Conducting Compliant Investigations

Mar 2021
PDA Item Number
Hardcover: 17363 | Digital: 18087
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In this book you will find many different approaches to conducting compliant investigations, where compliant is defined as meeting the requirements of the applicable regulatory documents.

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

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents

  1. Introduction by Jeanne Moldenhauer
  2. Why Investigations and Corrective Actions Matter by James L. Vesper
  3. Background on Deviations and Investigations by Jeanne Moldenhauer
  4. Planning the Investigation by Jeanne Moldenhauer
  5. Getting to the Heart of the Matter: Approaching Root Cause Analysis by Tim Sandle
  6. Preparing for and Conducting Successful Investigations Introduction by Scott VW Sutton
  7. Quality Control Chemistry Laboratory Investigations by Paula J. Shadle
  8. Production and Utility System Deviation Investigations by Jeanne Moldenhauer
  9. Documentation Error Investigations and Data Integrity: Data Integrity Issues by Jeanne Moldenhauer
  10. Investigating Sterility Test Failures by Tim Sandle
  11. Investigating Media Fill Failures by Jeanne Moldenhauer
  12. Levering Risk Assessments in Environmental Monitoring Investigations by Karen Ginsbury
  13. Microbiological OOS and OOT Investigations in Non-Sterile Pharmaceutical Manufacturing — A Contract Lab Perspective by Rick Jakober
  14. Compliant Investigations by Jeanne Moldenhauer
  15. Investigating Stabiliby Failures by Jeanne Moldenhauer
  16. Analyzing Product Impact in Investigation Review by Jeanne Moldenhauer
  17. How to Write a Good Investigation Report by Jeanne Moldenhauer
  18. Tracking and Trending Investigations by J. Edgar Guerzon

Appendix: Automated Systems for Tracking and Trending Investigations by Jeanne Moldenhauer

About the Authors

About the Editor

Jeanne Moldenhauer, Excellent Pharma Consulting, LLC has over 30 years of experience in the pharmaceutical industry. She is past chair of PDA's Environmental Monitoring/Microbiology Interest Group. Served on the Scientific Advisory Board of PDA, founded the Rapid Microbiology Users Group™ and is a member of ASQ and RAPS. She is the author of numerous journal articles and texts co-published by PDA and DHI: Steam Sterilization: A Practitioner's Guide, Laboratory Validation: A Practitioner's Guide and has edited and contributed to many volumes including the successful Environmental Monitoring book series, the Contamination Control series with Russell L. Madsen, Rapid Sterility Testing with Margarita Gomez and many other texts.