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2021 ISPE Aseptic Conference


VL21CEMAR1/SES112 - Regulatory and Industry Panel


Mar 17, 2021 10:15am ‐ Mar 17, 2021 12:00pm

Description

Regulatory and Industry Panel | The Regulatory and Industry Panel is one of the highlights of this conference. This session features questions and answers of the most daunting regulatory issues facing regulators and industry at this time. You will learn the most current perspectives of thought leaders regarding your most pressing challenges. The session is completely interactive, providing for a very rich experience. You will not want to miss this session.

Speaker(s):

  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA

Moderator(s):

  • David Doleski, Compliance Head for Biologics Quality Operations, Sanofi

Speaker(s):

  • Jörg Zimmermann, Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co.
  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA
  • Thomas J. Arista, Consumer Safety Officer, FDA/ORA
  • Rick Friedman, Deputy Director, Office of Manufacturing Quality, CDER/FDA
  • Brooke Higgins, Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality, FDA/CDER/OC/OMQ
  • Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)
  • Alan Moon, Senior GMDP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Robert Sausville, Director, Div. Case Management, FDA/CBER/OMPT/OCBQ

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