Amy Ganden

Amy Ganden
Quality Assurance and Methods Compliance Manager

Amy Ganden is the Quality Assurance and Methods Compliance Manager at PTL. 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 assurance department and ensures the quality management system complies with US FDA regulations and ISO/IEC 17025:2017 standard. She facilitates all regulatory inspections and accreditation assessments. Ms. Ganden also enjoys helping staff through the instrument qualification process and being involved in the review of method validations, method verifications and method transfers.

Ms. Ganden earned a Bachelor of Science degree in Biology from the University of Iowa.

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