Leah Andrews was an Investigator/Bioresearch Specialist/Pre-Approval Manager with the FDA for 17 years conducting bioresearch monitoring inspections for the Centers for Drugs, for Biologics, for Devices and for Veterinary Medicine nationally and internationally. For the past 9 years, as a consultant, she has nationally and internationally performed GCP/GLP audits, readiness assessments for PMAs, NDAs, & BLAs; developed training for FDA Inspection preparation and readiness; and assisted clients in responding to FDA inspection findings and regulatory actions.