Stephen Trombetta Hospira, Inc.

Stephen S. Trombetta is the Lead Global Director of Sterility Assurance at Hospira Inc. Mr. Trombetta has extensive industry experience in aseptic manufacturing and quality control including over 38 years of experience with major pharmaceutical companies like Novartis V&D, GlaxoSmithKline, Pfizer and Wyeth. Mr. Trombetta's experience includes process validation and sterile media fill trials in addition to development of qualification protocols. He has developed Best Practices for Aseptic Gowning and has conducted frequent training programs in aseptic processing, cleanroom behavior, aseptic technique as well as environmental monitoring. His training includes both laboratory personnel as well as manufacturing operators. Mr. Trombetta conducted cGMP training on aseptic practices, environmental monitoring, and gowning procedures for the FDA (CDER) in 2003 through 2008 and the EMEA in 2008 (Budapest Hungary). Mr. Trombetta attended Temple University Quality Assurance and Regulatory Affairs at Temple University and has a B.S. degree in Biology/Psychology from the Immaculata University. Mr. Trombetta is a former faculty member at the PDA's Training and Research Institute for Aseptic Processing Course. He was also an instructor at USP Training and Research for the USP <797> Sterile Compounding. He was a member of PDA Task Force TR13 for Environmental Monitoring.