Person
Osamu Shirokizawa
Osamu Shirokizawa is President and CEO of Life Scientia Ltd., an engineering consultancy firm specializing in pharmaceutical, biopharmaceutical, and ATMP manufacturing industries. He has more than 30 years of experience in providing a variety of engineering and compliance services to the industry. These include microbial control strategy, product sterility assurance, and cleaning validation.
Osamu has been an active PDA member for more than 25 years and currently serves on the PDA Board of Directors. He has been a representative of the PDA Japan Chapter (JPDA) since 2019. He is the current chair of the Kansai Study Group (KSG), which is one of the subcommittees of JPDA. He is a member of a task force for updating PDA Technical Report No. 29, Science and Risk Based Cleaning Validation, with the ongoing experience of developing several ASTM standard guides relating cleaning validation. He is one of the authors of PDA Points to Consider for the Engineering of Manufacturing of ATMPs as well.
Osamu has also been working in multiple volunteer activities led by the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. He took a key role in establishing and revising Japanese guidance documents for sterile products.