Yoko Nakai HORIBA Advanced Techno, Co., Ltd.

The GMP Committee for Aseptic Products is one of the technical committees of PDA Japan chapter. It is made up of ten groups, each with experts in their respective fields who are actively engaged in research and discussion. Study results of each group have been reported at annual microbiology symposium which the committee hosted and provided participants state-of-art and practical information. One of the groups, the Rapid Microbiological Method (RMM) Research Group consists of RMM users (pharmaceutical companies) and RMM system suppliers. By their collaboration, they provide application and implementation case studies from scientific, engineering, and regulatory point of view, and contribute to further improvements of quality and safety of pharmaceutical products by wide use of RMM in Japan. The speaker, Yoko Nakai represents the GMP Committee for Aseptic Products. She has been a project manager for RMM system development and applications at HORIBA Advanced Techno, Co., Ltd. since 2017. HORIBA has been a member of RMM implementation study team with Bayer Yakuhin, Ltd., and Azbil Corporation.