12:35 p.m. – 2:00 p.m. | P4: Panel Discussion
Moderator: Rick Watson, Director, Sterile & Validation CoE, Merck & Co., Inc.
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12:35 p.m. – 12:50 p.m. | Regulatory Considerations for the Assessment of Visible Particulates
Rukman S. De Silva, PhD, Chemist/Product Quality Reviewer, CDER, U.S. FDA
12:50 p.m. – 1:50 p.m. | Panel Discussion
Rukman S. De Silva, PhD, Chemist/Product Quality Reviewer, CDER, U.S. FDA
John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
Romain Veillon, Senior Manager, Vision Inspection & Leak Testing MSAT – Manufacturing Technologies, GSK Vaccines
Rick Watson, Director, Sterile & Validation CoE, Merck & Co., Inc.
1:50 p.m. – 2:00 p.m. | Closing Remarks and Final Wrap-up
John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
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