Barry M. Rothman

Barry Rothman joined Lachman Consultants in November 2011 and currently serves as a Director in Lachman’s Compliance Practice. Barry’s responsibilities with Lachman Consultants include the management of GMP audits and remediation projects. He earlier retired from US FDA after a 37-year career, serving as Acting Director, in the CDER Compliance Division of Good Manufacturing Practice Assessment. In that position, Barry was responsible for managing the CDER Pre-approval Inspection Compliance Evaluation Program. As a senior Compliance official, Barry was involved with the approval and resolution of enforcement actions involving GMP, product quality and data integrity violations, including Warning Letters, Seizures, Consent Decrees, Import Alerts, and Application Integrity Policy. Earlier in Barry's career he served seventeen years as a FDA Field Investigator. Barry is the recipient of numerous FDA honor awards and commendations.