Michael Sheehon

Michael Sheehon has a systematic approach of delving into the details to ensure full adherence with FDA guidelines. He looks beyond just the implementation of processes to verify that they are effective, and insists on thorough investigations when issues arise. He keenly observes the environmental controls in place to ensure the product's quality is not compromised.

Michael Sheehon seems to be a meticulous FDA auditor with a keen interest in quality control, root cause analysis, and environmental monitoring settings. He appears to be particularly attentive to complete adherence to the Quality Unit's responsibilities, effective investigation and preventive actions for unexpected incidents such as the presence of foreign material, and appropriateness of environmental process simulations and controls.