Vice President, Regulatory and Quality
Ms. Janet Bowen has almost 30 years of experience in the areas of sterile pharmaceuticals, biopharmaceuticals, oral solid dosages, and medical devices. During her career, she has held positions in quality, regulatory, compliance, batch/lot release, and compliance/regulatory consulting. Ms. Bowen has prepared companies for many different agency inspections, setting up quality systems, and to prepare the associated submissions. Ms. Bowen is knowledgeable in the requirements of FDA, HSA, EMA, CFDA, PMDA, TGA, and Health Canada, as well as other agencies.
Ms. Bowen has a B.S. in Chemistry and a B. S. in Business Management. During her career, she has given presentations on Process Validation, Inspection Readiness, Combination Products, Quality by Design, and Aseptic Processing as well as others. She is a member of ISPE, PDA, ASQ, RAPS and is an active member of several regulatory Interest Groups within these organizations.