Dr. Chiaruttini spent 10 years at the US FDA Center for Drug Evaluation and Research as a microbiology reviewer where she was a member of the Emerging Technologies Team, served as an expert witness for the US Department of Justice, and was involved in the evaluation of novel pharmaceutical products and compliance actions. Her expertise includes development of microbial control strategies, sterilization validation, aseptic processing, microbial deviation investigations, and she has direct experience with the review and approval of novel technologies and sterilization practices. She coauthored multiple FDA Guidance documents as well as domestic and international standards regarding microbial control.