Hue Kwon (Member, RAQAB at Parenteral Drug Association)

Hue Kwon

Member, RAQAB at Parenteral Drug Association

Dr. Hue Kwon served leads a global quality team providing GxP quality and compliance oversight for the end -to-end drug development and lifecycle.

Hue was the former Vice President and Quality Team Leader at Samsung Bioepis, and prior to joining Samsung Bioepis, she was the Head of Business Management and Head of Quality and Compliance in Roche, as a member of a senior management team and leading international GxP capability building and interaction with foreign regulatory agencies to influence in the decision making and building consensus.

She also served as a senior advisor consultant in regulatory strategies for multiple organizations and global matrix environment and for digital health strategy, global IT and global operational alignment project in drug development.

Until December 2010, she served at US FDA for about 9 years on the development of regulatory guidance, emerging regulatory strategy and review and data integrity inspections.

Peter Qiu (External Advocacy Lead, APAC at Roche Genentech)

Peter Qiu

External Advocacy Lead, APAC at Roche Genentech

Dr. Peter Qiu is the External Advocacy Lead for Asia Pacific at Roche Genentech with over 13 years of experience working with the US FDA. He was the Division Director in the Division of Biotechnology Manufacturing, Office of Pharmaceutical Manufacturing Assessment, CDER. He led the assessment of manufacturing processes, facilities, and microbiological control for CDER’s Biologics License Application review and inspection program.

Dr. Qiu has extensive knowledge in microbial controls and sterility assurance assessment as well as in pre-license and pre-approval inspections for biotech products.

Dr. Qiu graduated from the University of Southern California with a Ph.D. in Biological Sciences.

Richard Chai (Senior Technical Service Manager at STERIS Corporation)

Richard Chai

Senior Technical Service Manager at STERIS Corporation

Richard Chai is a Technical Service Manager in the Life Sciences Division of STERIS Corporation. He currently provides global technical support related to process equipment cleaning and contamination control in cleanrooms. Richard has more than 20 years of industry experience in manufacturing, validation and technical support. He has published several articles in contamination control and is a frequent speaker at industry events.

MW

Mr. Bayu Wibisono, S.Si, Apt., M.A.B. (invited)

Director of Directorate of Drug, Narcotic, Psychotropic, and Precursor Production Supervision

Deputi Bidang Pengawasan Obat, Narkotika, Psikotropika, Prekursor, dan Zat Adiktif - Direktorat Registrasi Obat

Indonesia FDA BPOM