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:
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.