Lisa Hornback is a highly experienced professional in the FDA-regulated industry, currently serving as the Principal Consultant at HORNBACK CONSULTING, LLC since January 2006. With a strong focus on strategic consulting, Quality System development, audits, training, and interaction with the FDA, Hornback also contributes as Teaching Faculty at AAMI, where courses on design control, quality systems, supplier management, and process validation are taught. Previously, Hornback instructed courses on supplier and risk management at PDA and served as a Principal Consultant for PAREXEL, providing compliance consulting for the medical device and pharmaceutical sectors. Experience at the FDA includes conducting inspections as a Field Investigator and Midwest Regional Medical Device Expert. Earlier in the career, medical laboratory technology work was performed at Mercy Health/Lourdes Hospital. Hornback holds a BS in Medical Technology from Southeast Missouri State University, graduating Cum Laude.
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