معرفی
Georgiann Keyport serves as an Instructor in the Regulatory Science & Medical Device Development program at the University of St. Thomas School of Engineering. She concurrently operates as founder and Senior Advisor of Canopy Regulatory Solutions Inc., leveraging 30+ years of industry experience across medical device, biologic, and pharmaceutical regulatory domains.
Her academic qualifications include:
- Regulatory Affairs Certification (RAC) from RAC University of Minnesota
- MS in Laboratory Medicine with Immunology Concentration from College of St. Catherine
- BS in Biology from College of St. Catherine
Ms. Keyport specializes in global regulatory strategy for medical products, with demonstrated expertise in US/EU/Japan/Canada/Australia submission frameworks (510(k), PMA, IDE, CTD), quality system compliance (QSR/GMP), and combination product development. Her work bridges scientific innovation with regulatory requirements for market authorization and post-market surveillance.
Professional recognition includes:
- Fellow of the Regulatory Affairs Professionals Society (RAPS)
She actively contributes to graduate education through courses like ETLS 731: Combo Products, Drugs & Biologs, focusing on FDA center jurisdiction determination and regulatory pathway differentiation between medical devices, drugs, and biologics.
