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Session Chair(s)
Steven B. Binion
Director, Policy, Technology, and Communication - Corporate Regulatory Affairs
Becton Dickinson, United States
Speaker(s)
CGMP Final Rule
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC
Industry Perspectives
Alex Wesolowski
Becton, Dickinson and Company, United States
Vice President, Corporate RA
Industry Perspectives
Jeanmarie Sales
Medtronic, Inc., United States
Distinguished Reg Affairs Advisor
CDER, CDRH and CBER Perspectives
Edward Patten, MS
FDA, United States
Associate Director for Manufacturing Science, CBER
CDER, CDRH and CBER Perspectives
Steven Hertz, MBA, MS
FDA, United States
Consumer Safety Officer, Office of Pharmaceutical Quality, CDER
CDER, CDRH and CBER Perspectives
M. Isabel Tejero del Rio, MD, PHD
FDA, United States
Quality Systems Working Group Lead, DMQ, OC, CDRH
CDER, CDRH and CBER Perspectives
Melissa Torres, MS
FDA, United States
Associate Director for International Affairs, CDRH
Panel Discussion
All Session Speakers, United States