Manager of Quality Assurance and Methods Compliance
Amy Ganden is the Manager of Quality Assurance and Methods Compliance. Ms. Ganden joined PTL in 2000 as a Particle Characterization Chemist. Throughout her career, she has held a variety of positions within the Laboratory and Quality Assurance departments. Ms. Ganden has provided client trainings and presentations relative to particle characterization, as well as testimony in patent infringement litigation cases.
In her role as Manager of Quality Assurance and Methods Compliance, Ms. Ganden oversees PTL’s quality system, ensuring compliance with US FDA regulations. She facilitates all on-site audits and inspections by clients and regulatory entities. Ms. Ganden also coordinates instrument qualification activities and manages large-scale projects related to method validation, verification and transfer. She is also currently a member of the Institute of Validation Technology Editorial Advisory Board. Ms. Ganden earned a Bachelor of Science degree in Biology from the University of Iowa.