Steven Kehoe
TCG Consultant
Steve Kehoe has over 15 years of experience combined between nine years as an investigator with the US Food and Drug Administration (four of those years as a member of the Dedicated Foreign Drug Cadre performing high-profile international drug manufacturing inspections and Pre-Approval inspections), experience as a Quality Control Manager at a small OTC manufacturer, and the last 6 years as a pharmaceutical consultant focusing on Quality Management System remediation and FDA inspection preparation activities for a variety of different clients.
Mr. Kehoe has been involved in several efforts for Pre-Approval Inspection preparation, and has performed a variety of different GMP assessments, as well as conducting GMP audits, assisting in improvement of laboratory investigations, and as a hands-on expert in qualification of laboratory instrumentation. He has also been a strong advocate for improvements in data integrity practices and has assisted firms in reducing backlogs of Quality Investigations and CAPAs.
He earned his Bachelor of Science and subsequently his Master of Science degrees in Chemistry from the University of Wisconsin-Madison.