Beth Fulton

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ValSource, Inc.
Consultant (Quality Risk Management)
Beth Fulton, MS, is a Consultant with ValSource. Beth is an industry leader in the development and implementation of innovative approaches to quality risk management (QRM), especially situational application of QRM tools. She is a subject matter expert in quality systems design and implementation for pharmaceutical, biopharmaceutical, cell therapy, and combination products. She has a BS in food science from Cornell University, an MS in zoology from University of New Hampshire, and an MS in food science and human nutrition from the University of Maine. She joined ISPE in 2022.

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The validation of media and buffer mixing is a continuing area of resource constraint in the pharmaceutical industry. These validations require materials, validation associates’ time, and the use of equipment and processing areas. This article proposes a risk-based life cycle for minimizing mixing validation resource inputs, with the objective of optimizing validation efforts through the use...