David B. Lerner

David specializes in transforming business operations within quality, R&D, regulatory and manufacturing operations in the pharmaceutical and medical device industry. David has provided guidance across regulatory, quality and clinical functions. David is also a GCP and GMP quality expert, providing advice to on their Quality Management Systems, and preparing and responding to regulatory authority inspections. David was a co-author of the GAMP MES guide Recently, David has been working on implementation of AI used cases within Life Science, including UST's Sentry AI solutions.