Written by subject matter experts, these chapters are organized by topic and excerpted from volumes in the Contamination Control in Healthcare Manufacturing series
- Contamination Control Risk Assessment by Tim Sandle. Chapter excerpted from Volume 1, Chapter 18 published May 2013.
- Contamination Risks and the Patient by Mark Hunter, Michelle Luebke, and Mark Pasmore. Chapter excerpted from Volume 2, Chapter 4 published March 2014.
- New Risk Assessment Tools for Sterile Products by Guenther Gapp. Chapter excerpted from Volume 2, Chapter 8 published March 2014.
- Risk Management of Microbial Contamination Control in Aseptic Processing and Interventions Risk Assessment Model (IREM): The Use of Critical Thinking to Make Informed Decisions by Hal Baseman and Mike Long. Chapter excerpted from Volume 3, Chapter 11 published June 2014.
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 3.60 MB)
About the Editors
Jeanne Moldenhauer, Excellent Pharma Consulting, has nearly 30 years of
experience in the pharmaceutical industry. She chairs the PDA Environmental
Monitoring/Microbiology Interest Group, serves on the PDA Scientific Advisory
Board, founded the Rapid Microbiology User`s Group TM, and is a member of ASQ
and RAPS. She is the author of Recent Warning Letters Review for Preparation of a Non-Sterile Processing Inspection, Volume 2; Recent Warning Letters Review for Preparation of an Aseptic Processing Inspection and the Editor of Environmental Monitoring: A Comprehensive Handbook Series; Steam Sterilization: A Practitioner`s Guide; Laboratory Validation: A Practitioner`s Guide; Systems Based Inspections for Pharmaceutical Manufacturers and Thermal Validation in Moist Heat Sterilization among numerous other recent publications. She is the winner of the 2010 and 2005 PDA/DHI Distinguished
Russell Madsen, President, The Williamsburg Group, LLC, has led the organization since its founding in 2003
and has over forty-five years of experience in the pharmaceutical industry. The Williamsburg Group provides expert
pharmaceutical consulting services including CGMP compliance, quality systems, aseptic processing and sterilization,
sterilizing filtration, design review, due diligence and regulatory liaison.