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2022 ISPE Aseptic Conference

Interactive Regulatory Panel


Mar 15, 2022 3:30pm ‐ Mar 15, 2022 5:00pm


Description

Interactive Regulatory Panel | This is your opportunity to pose your most pressing quality and regulatory questions directly to a panel of respected FDA thought leaders in the aseptic processing space. This moderated and interactive discussion continues to be a much anticipated and highly rated session for this conference and is always informative; providing insights exclusively to conference attendees. together has changed the role of the industry and has driven value for the world. In our closing plenary session, we will hear from Joydeep Ganguly, SVP of Gilead, regarding how 2020 redefined the role and the value drivers of their efforts. We will also have Rick Friedman, Deputy Director, Science & Regulatory Policy, Office of Manufacturing Quality, CDER/FDA speak about the advantages of modern manufacturing. The session will conclude with a panel discussion including industry and regulatory leaders.

Speaker(s):

  • Michael G. Higgins, Senior Compliance Advisor, Roche/Genentech
  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA
  • Paul A. Gustafson, 2022 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor, Regulatory Operations and Enforcement Branch (ROEB), Health Canada
  • Rick Friedman, Deputy Director, Office of Manufacturing Quality, CDER/FDA
  • Brooke Higgins, Senior Policy Advisor for the Global Compliance Branch 3, FDA
  • Robert Sausville, Director, Division of Case Management, FDA/CBER/OMPT/OCBQ
  • Joerg Zimmermann, Vetter Pharma-Fertigung GmbH & Co., Vice President, Vetter Development Service, External Affairs
  • Thomas J. Arista, Consumer Safety Officer, FDA/ORA

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