Jeanne Moldenhauer, Vice-President of Excellent Pharma Consulting, 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 20 years, founded the Rapid Microbiology User’s Group™, and is a member of ASQ and RAPS. She is the author/editor of many books, including Steam Sterilization: A Practitioner’s Guide, Laboratory Validation: A Practitioner’s Guide, Environmental Monitoring: A Comprehensive Handbook (Volumes 1-8), Contamination Control Volumes 1-4 (with Russ Madsen), System’s Based Inspections for Pharmaceutical Manufacturers, Preparing for an FDA Inspection: Review of Warning Letters (Sterile and Non-Sterile), and Biological Indicators, and numerous publications (book chapters and magazine articles).