Susan M. Leister, MBA, PhD, CQA, CSSBB, has over 20 years of experience covering the pharmaceutical, medical device, and clinical arena, including extensive working knowledge of GCP, cGMP, GLP, ICH E6 GCP, and HSP. She has managed various inspections including ISO, CE Mark, Health Canada, MHRA, EMA, DEA, Maryland Board of Pharmacy, and FDA. Dr. Leister provides QM oversight to multiple government and commercial clients from large pharma to the small biotech startup. She currently oversees a QA auditing team comprised of ~ 20 FTEs who verify monitoring performance and internal audits with a global reach, conduct quality trend analysis including analysis of reports and associated data, and provides recommendations and quality consultative services. She is experienced in managing NIH drug repository and stability lab for domestic and international clinical trials and is skilled in developing plans for resolutions to deviations and CAPAs, analyzing QA/QC results, and recommending process improvements with 6 Σ. Dr. Leister is seasoned in mock inspections and overall inspection readiness.

About Barnett International:
Barnett International is a leader in training and resources for clinical research professionals. The Barnett approach is unique in that it combines content development expertise with a high level of subject matter experience, engaging instructional design and a multi-platform approach. Our education and training portfolio offers diverse options for all types of learners. Barnett helps clients get the most out of their research and development dollars by managing change effectively, improving organizational performance, and enhancing staff knowledge. The "Barnett Difference" is evident in our deep understanding of the clinical research process and in the rapid and tangible performance improvements we deliver.