Content Contributor Susan Leister

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.

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FDA Inspections: From Site Preparation to Response FDA Inspections: From Site Preparation to Response
Featured

Covers regulatory inspections of clinical investigators and sites, including mock inspections, 482s, 483s, warning letters, communication, and CAPA plans.

FDA approved medical injection pens
Good Manufacturing Practices (GMP) Good Manufacturing Practices (GMP)
Featured
Series: Good Manufacturing Practices (GMP)

An in-depth introduction to GMP for pharmaceuticals.

Manufacturing technician inspecting a pill
Comprehensive CRC Comprehensive CRC
CME/CEU
Series: Clinical Research Coordinator (CRC)

Provides clinical research professionals with basic and advanced training tailored to the CRC’s critical role in the conduct of clinical trials.

Research coordinator working at computer
Clinical Research Coordinator (CRC) Advanced Clinical Research Coordinator (CRC) Advanced
CME/CEU
Series: Clinical Research Coordinator (CRC)

This course provides clinical research professionals with advanced training tailored to the CRC’s critical role in the conduct of clinical trials.

doctor looking at an x-ray of a human spine
FDA Inspections of GMP Facilities: How to Be Inspection Ready FDA Inspections of GMP Facilities: How to Be Inspection Ready
Featured
Series: Webinars

Discusses the FDA’s approach to inspecting GMP facilities and the ways that facilities can prepare for inspections.

gmp webinar card
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