Beth Fulton

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ValSource, Inc.
Consultant (Quality Risk Management)
Consultant who has been designing and implementing quality risk management, quality, and training systems within industry for over a decade. Subject Matter Expert in risk management, opportunity assessment, and event management, especially appropriate situational application of tools (e.g. FMEA, PHA, RRF, HACCP, Impact-Effort, Process Mapping, 8D, 6M, 5-why, What-If, etc.). Leader in teaching critical thinking skills and questioning attitude.

Related Articles

Examples of variables that represent the worst-case recipe(s) within a vessel or functionally equivalent vessels
Technical
Risk- And Science-Based Media and Buffer Mixing Validations

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...