Thu Truong, J.D.
Thu Truong, J.D., Analytical, Bioanalytical and Quality Control Laboratory Specialist, experienced in auditing R&D and Quality Control laboratories for both small and large molecules under state, federal and corporate policies. She has 30+ years of pharmaceutical and consulting experience and brings a solid working knowledge of different audit types including cGMP, API, PAI, Application Integrity Policy (AIP), and CRO bioanalytical laboratories. Ms. Truong is an experienced auditor of study data and supporting records for validity and regulatory compliance of INDs, NDAs, and ANDAs as well as BE/BA studies. In addition, she has an excellent working knowledge in computer validation, cGLP and cGCP including audits of electronic study data, contract facilities, and clinical sites. Her experience encompasses various dosage forms including solids, liquids, creams, ointments, and parenterals. Her special focus is on laboratory data integrity, including the forensic approach to determine the scope and gravity of data integrity issues.