Conducting Compliant Investigations – 2nd edition

New Title - publication date October

Editor: Jeanne Moldenhauer

ISBN:   ebook – 978-1-917195-24-9    800pp   £240
ISBN:  Hardback – 978-1-917195-25-6    800pp  £270

This book provides many different approaches to conducting compliant investigations, where compliant means that they will meet the requirements in the applicable regulatory documents.  This new 2nd edition expands on the first edition of 2021 and includes eight extra chapters that cover the topic in even greater depth. It provides invaluable information on conducting investigations that will be acceptable to regulatory investigators and that can lead to significant regulatory risk reduction.

Jeanne Moldenhauer is Vice-President of Excellent Pharma Consulting and has more than 30 years’ experience in the pharmaceutical industry.  She chaired the Environmental Monitoring/Microbiology Interest Group of PDA for more than 15 years, served on the Scientific Advisory Board of PDA for many years, founded the Rapid Microbiology User’s Group™, is a member of ASQ and was a member of RAPS for many years.  She is the author of numerous books including: Steam Sterilization: A Practitioner’s Guide, Laboratory Validation: A Practitioner’s Guide, Environmental Monitoring: A Comprehensive Handbook (Volumes 1-9), System’s Based Inspections for Pharmaceutical Manufacturers, Preparing for an FDA Inspection Review of Warning Letters (Sterile and Non-Sterile), co-author of Biological Indicators, and many others and numerous publications (Book Chapters and Magazine Articles).

Chapter titles and authors

1.    Introduction – Jeanne Moldenhauer
2.    Why Do Investigations (Regulatory Requirements for Investigations) – Jeanne Moldenhauer
3.    Regulatory Observations Relative to Investigations in USA – Jeanne Moldenhauer
4.    Regulatory Observations in EU – Tim Sandle
5.    Background on Deviations and Investigations – Jeanne Moldenhauer
6.    Planning the Investigation – Jeanne Moldenhauer
7.    Root Cause Analysis – Jeanne Moldenhauer
8.    Root Cause Analysis Tools (Quality and Engineering Tools) – Jeanne Moldenhauer
9.    Laboratory Investigations Microbiology – Tim Sandle  
10.    Laboratory Investigations – Chemistry  –  Paula Shadle
11.    Personnel Monitoring and Handling Investigations – Marsha Steed
12.    Production and Utility Investigations – Jeanne Moldenhauer
13.    Sterilization Failure Investigations – Jeanne Moldenhauer
14.    Labeling Investigations – Jeanne Moldenhauer 
15.    Documentation Error Investigations – Jeanne Moldenhauer
16.    Data Integrity: Data Integrity Issues – Jeanne Moldenhauer
17.    Sterility Failure Investigations – Tim Sandle
18.    Media Fill Failures – Jeanne Moldenhauer
19.    Environmental Failure Investigations  Karen Ginsbury
20.    Vendor and Contractor Investigations – Rick Jakober
21.    Complaint Investigations – Jeanne Moldenhauer 
22.    Stability Failure Investigations –  Jeanne Moldenhauer
23.    Determining the Product Impact Analysis asked – Siegfried Schmitt
24.    How to Write a Good Investigation Report – Jeanne Moldenhauer
25.    Tracking and Trending Requirements – Jeanne Moldenhauer
26.    Automated Systems for Tracking Systems/Deviations – Jeanne Moldenhauer