Lisa Hornback Hornback Consulting, LLC

Lisa Hornback, Principal Consultant of Hornback Consulting, LLC, has over 15 years experience regarding interpretation and implementation of FDA regulatory requirements for pharma, devices, and biologics. For 11 years, Lisa has been a Compliance Consultant, where she has provided expertise and assistance to FDA regulated industry in the US and overseas in resolving FDA compliance issues. Lisa has designed and implemented quality system solutions, guided companies through resolution of FDA Warning Letters and Consent Decrees, audited operations for compliance to FDA and ISO requirements, and provided training on a variety of technical and regulatory topics.

Prior to entering the world of consulting, Lisa was an FDA Field Investigator and the FDA's Midwest Regional Medical Device Expert. In this role, Lisa was responsible for compliance inspections of highly complex pharma, device, and biologic industries and obtained extensive experience in FDA's approach to initiation and resolution of Warning Letters, Consent Decrees, and product seizures. Lisa obtained a Bachelor of Science in Medical Technology and has worked extensively in the hospital setting, which has provided her with the end-user perspective on the products regulated by FDA. Lisa is a member of the PDA Training Board and member of the PDA training cadre and has been a speaker at multiple conferences on topics such as combination products, risk management and quality systems. Lisa is also a course instructor for AAMI on the topics of Purchasing Controls and Quality Systems.