Master's Series

Concurrent Session

M21 - Connected Device Validation and Quality Best Practices

Monday, April 30
1:30 PM - 2:30 PM
Location: WSCC 615-617

Level: Advanced

No matter where you are or what you are doing chances are that you are using, or are being exposed to technology in ways that were not even possible 20 years ago. It is now common to be using connected devices that that offer us increased flexibility, access to the internet, and the ability to have health monitoring at home. Surprisingly there are very few government regulations guiding the development, manufacture and management connected device systems. This presentation reviews the results of a multi-industry survey that was conducted, by the author, to identify the various verification and validation practices industries are utilizing in the absence of specific regulatory guidelines.
This presentation will review the following:
• Identify the activities that are currently being done in various industries to ensure high quality performance of the connected devices;
• Review the results from a survey created to learn the best practices form multiple industries involved with connected devices,
• Describe the new responsibility that the quality department in this connected device market;
• Identify some of the voluntary international standards that support the connected device systems market.

Learning Objectives:

Carolyn Wright

Connected Device Principal Quality Engineer
Wyoming, Michigan

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 in 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.


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Michael Kirchner



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M21 - Connected Device Validation and Quality Best Practices


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