ARTICLES BY MEGAN MARSHALL
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![Risk Decision]( "A Tactical Approach To Risk Management At The System-Level")
A Tactical Approach To Risk Management At The System-Level7/10/2019Many biotechnology/pharmaceutical organizations are in the early stages of developing their risk management process. For the most part, we tend to see this process developing at the clinical trial level. The struggle with implementing these practices solely at the trial level is that it quickly becomes inconsistent and obsolete. Study teams are taking the time to assess risk as it applies to their trial, but the information gained is seldom shared cross-functionally or upward through an organization. It is more of a “going through the motions” type practice — which is then filed away, never to be utilized again.
Megan Marshall
Megan Marshall has concentrated experience in quality assurance and clinical diagnostics focusing in immunology and infectious disease testing. At Halloran Consulting Group, she is responsible for writing and evaluating procedures, identifying and executing process improvements, and assisting with CAPA development and various audits. Previously, Marshall was employed by Oxford Immunotec, where she worked as a quality assurance specialist providing support across a diverse operations group that included diagnostics, device manufacturing, and research and development. Marshall was a team member responsible for obtaining FDA (CBER) licensure for a biologic used in the screening of donated blood units for the detection of tick-borne parasite Babesia microti.