15:00 – 16:30 | P8: Aseptic Process Simulation and Environmental Monitoring
Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc.
Aseptic process simulation (APS) has been identified as one of the key aspects of aseptic process control and monitoring. This session will review the related changes and begin discussing the interpretation and implementation of these recommendations and requirements. The presentations will focus on the Annex 1 requirements for APS (media fills) and environmental and process monitoring, including the new requirements and considerations for qualifying and operating a clean area and the extensive new requirements needed to successfully validate an aseptic process.
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15:00 | Environmental and Process Monitoring
Marc Glogovsky, MS, Business Unit Manager/Senior Consultant – Microbiology, ValSource, Inc.
15:20 | Contamination Control Strategy Development
James Wamsley, Consultant, ValSource, Inc.
15:40 | Day 2 Report Out, Q&A, and Panel Discussion
Frederic B. Ayers, Research Scientist, Eli Lilly and Company
Angie L. Bragdon, MS, Senior Principal Scientist - Sterility Assurance Technology, Eli Lilly and Company
Marc Glogovsky, MS, Business Unit Manager/Senior Consultant – Microbiology, Valsource, Inc.
William Peterson, Associate Director of Engineering, Merck & Co., Inc.
Mike J. Sadowski, Lead Scientist, Baxter Healthcare
Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC
LT Seneca D. Toms, MS, MSEH, RAC, National Expert, Drugs, ORA, U.S. FDA
James Wamsley, Consultant, ValSource, Inc.
16:25 | Closing Remarks from Workshop Co-Chairs
Frederic B. Ayers, Research Scientist, Eli Lilly and Company
Tracy Moore, Director, TM Pharma Group Ltd |