Carolyn Wright

Carolyn Wright, has 20+ years of experience as a process development, manufacturing, validation and quality engineer as well as department leadership roles in these areas. She started her career at Eastman Kodak in Rochester New York then moved to a transdermal development and manufacturing company in Grand Rapids, MI. She is currently with Amway Ada, Michigan and held leadership and engineering roles in the quality and regulatory departments. Carolyn is a certified Six Sigma Black Belt, has a Bachelor of Science Degree in Material Science and Engineering from Michigan State University and a Regulatory Affairs Masters Degree from Northeastern University and is pursuing her Doctorate of Regulatory Science at the University of Southern California.

Carolyn is a technical expert in coating technology, has performed the development work for several new transdermal drug/device combination products including the CMC section of multiple ANDA and NDA submission. As a validation engineer she has written and executed multiple equipment qualifications, process and packaging validations, software validations and utility qualifications. She is very familiar with the FDA regulatory requirements of 21 CFR parts 110, 111, 210, 211 and 820 and the ISO 13485 standard. Carolyn has held management responsibility for corporate new technology regulatory assessments and product safety and is currently the Quality lead engineer for Amway’s connected devices.

Validation Week 2021


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