Sterility testing remains a critical component of batch release and overall sterility assurance
Sterility testing remains a critical component of batch release and overall sterility assurance. This webinar provides a practical overview of compendial approaches, linking method selection, media considerations, and workflow execution to product-specific needs. Participants will explore testing strategies aligned with USP General Chapter <71> Sterility Testing alongside modern, rapid approaches, with emphasis on risk-based decision-making, operational efficiency, and alignment with key microbiological chapters to support robust, compliant sterility programs.
Learning Objectives:
- Explain sterility testing within a holistic sterility assurance strategy
- Differentiate methods based on product characteristics
- Select appropriate media and evaluate bottled formats
- Identify critical controls in traditional sterility testing workflows
- Describe principles and benefits of rapid sterility methods
Presenter: Leslie Furr, Principal Scientist, United States Pharmacopeial Convention (USP)
Leslie Furr is a Principal Scientist in the Microbiology Unit at the United States Pharmacopeial Convention (USP). She has been with USP since 2018, serving as a documentary standards scientist for the Microbiology Expert Committee (MEC). In this role, she contributes to the development and revision of microbiology standards and guidance for global stakeholders. Leslie also serves as the primary liaison for the Endotoxins and Pyrogens Subcommittee, an MEC subcommittee focused on documentary standards for this topic.
She holds a B.S. in Microbiology from the University of North Carolina at Charlotte and an M.S. in Pharmaceutical Sciences from the University of Florida. Leslie has been certified by the American Society for Microbiology as a Specialist Microbiologist in Pharmaceutical and Medical Devices since 2012.
Prior to joining USP, she spent 14 years in the pharmaceutical industry as a Senior Microbiologist, focusing on method development, research and development, and manufacturing support.
