Susan Leister, BS, MBA, PhD, CQA, CSSBB
Technical Resources International Inc. & University of Phoenix
Dr. Susan Leister serves as the Vice-President of Quality and Compliance at Technical Resources International Inc. and faculty for the University of Phoenix in both graduate and undergraduate studies with over 20 years of experience in the pharmaceutical, biotech, and medical device industry. She has a Bachelor’s Degree in Biochemistry and Molecular Biology, an MBA, a Doctorate in Organization & Management with a focus in Leadership, and holds certifications from ASQ as Certified Quality Auditor and Six Sigma Black Belt. She has broad experience in GXP and has led numerous regulatory inspections and built quality systems from the ground up.
Browse This Author's Contributions
FDA Inspections: From Site Preparation to Response
Covers regulatory inspections of clinical investigators and sites, including mock inspections, 482s, 483s, warning letters, communication, and CAPA plans.
Introduction to Good Manufacturing Practices (GMP)
An in-depth introduction to GMP for drugs and pharmaceuticals.
Provides clinical research professionals with basic and advanced training tailored to the CRC’s critical role in the conduct of clinical trials.