Janet Bowen is Vice President for Regulatory, Quality, and Quality Control for PrIME Biologics (Singapore and Sydney). She has over thirty years of experience in the areas of sterile manufacture of pharmaceuticals, biopharmaceuticals, and medical devices. During her career, she has held positions as supervisor, manager, project director, and general manager, all of them for the pharmaceutical industry in quality, compliance, validation, batch/lot release, and compliance consulting. Ms. Bowen has vast experience in the sterile processing and environmental monitoring requirements of FDA, EU, PMDA, TGA, Asia, and Health Canada, as well as other agencies. Ms. Bowen has a B.S. in chemistry and business management. She has given presentations on Aseptic processing, ICH guidance, and other regulations related compliance for ISPE domestically and internationally.