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After Yes - Navigating the Rules of the Road in Today's Marketplace
Panel Session
Regulatory, Quality and Good Manufacturing Practices
Ellen Kondracki
Vice President, Sustainability & EHS
BD
Phil Cogdill, MBA
Sr. Director of Quality, Sterilization & Microbiology
Medtronic
Dan Carestio
Chief Operating Officer
STERIS Corporation
Suzanne Schwartz, MD, MBA
Director Office of Strategic Partnerships & Technology Innovation, CDRH
FDA
Steve Yeadon
VP, QA Peripheral Intervention & Global Sterility Assurance
Boston Scientific
A panel of FDA and industry experts on sterilization processes, and environmental health and safety, will discuss the impact of emerging federal and state efforts to strengthen oversight of ethylene oxide (EtO) emissions that result from EtO use in medical device sterilization. Topics covered will include potential challenges MedTech companies could face in achieving and demonstrating compliance under evolving standards, and other potential impacts of changing EtO regulations on industry and public health.
