FDA Director Alonza Cruse to Deliver Keynote Address at the 2020 ISPE Aseptic Conference

10 February, 2020
Alonza Cruse
Director, Office of Pharmaceutical Quality Operations
FDA/ORA
keynote Speaker

ISPE announced Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA, as a newly confirmed keynote for the 2020 ISPE Aseptic Conference, taking place 2–3 March 2020 in North Bethesda, Maryland.

His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with the FDA’s Center for Drug Evaluation & Research and the Center for Veterinary Medicine. Additionally, he is leading ORA’s pharmaceutical collaboration efforts under the Program Alignment initiative.

Alonza Cruse will provide current regulatory perspectives on aseptic processing during his keynote presentation. He is also a featured panelist in the Interactive Regulatory Panel session, where he will answer the most pressing quality and regulatory questions directly with six FDA colleagues, including:

Brooke Higgins
Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality
FDA/CDER/OC/OMQ
Christine A. Harman, PhD
Chemist, Review Branch 1
FDA
Jie He
Facility Inspection and CMC Review Branch 2
US FDA
Richard L. Friedman
Deputy Director, Science & Regulatory Policy
CDER/FDA
Robert Sausville
Director, Div. Case Management
FDA/CBER/OMPT/OCBQ
Zhihao Qiu, PhD
Director (Acting), Office of Pharmaceutical Manufacturing Assessment
FDA/CDER/OPQ/OPF

Now in its 29th year, the 2020 ISPE Aseptic Conference has established itself as the pharmaceutical industry's leading source on advancing aseptic and barrier operations and providing invaluable opportunities for peer-to-peer learning through interactions with industry and regulatory leaders.

View Agenda