Zhihao Peter Qiu

Peter joined Roche/Genentech in 2022 from Innovent Biologics, China, where he was Chief Quality Officer. Prior to Innovent, Peter spent 14 years at FDA in multiple roles of increasing leadership responsibilities in the Office of Compliance and Biological Quality (OCBQ), Center for Biological Evaluation and Research (CBER), Office of In vitro Diagnostic Devices, Center for Devices and Radiological Health (CDRH), and the Office of Compliance (OC) and the Office of Pharmaceutical Sciences (OPMA), Center for Drug Evaluation and Research (CDER), where his most recent role was Division Director of the Division of Biotechnology Manufacturing in OPMA, responsible for managing the scientific review and quality evaluation of the manufacturing controls and facilities for Biologics license applications (BLA) and conducting pre-license/pre-approval inspections for CDER regulated biological products. Before joining FDA, Peter spent ten years in biotech and device industry, primarily, in R&D and GMP manufacturing.

Peter has a Bachelor of Science in Biotechnology from Shanghai University of Sciences and Technology and a Ph.D in Biological Sciences from the University of Southern California.

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Thu. February 23 | 11.00am – FDA’s Regulatory Review and Inspection of Biological Products Manufactured Using Aseptic Processing

• FDA’s regulatory requirements for Biologics License Applications. The presentation will also cover regulatory guidance for sterile products manufactured by aseptic processing.
• FDA’s application review process for biological products manufactured by aseptic processing.
• FDA’s Pre-license and pre-approval inspection coverage for aseptic processing.