Thu Truong, J.D.
Senior Associate, is an Analytical, Bioanalytical and Quality Control Laboratory Specialist experienced in auditing R&D, Stability, Bioanalytical, and Quality Control laboratories under state, federal and corporate policies. She has over 18 years of pharmaceutical and consulting experience and brings a solid working knowledge of different audit types including cGMP, API, PAI 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 includes various dosage forms including solids, liquids, creams, ointments, and parenterals.