Evaluate Center for Drug Evaluation and Research (CDER) Bioresearch Monitoring (BIMO) Inspections of Clinical Investigators and Sponsors - Miah Jung, Pharm.D., M.S., Pharmacologist, Office of Scientific Investigations, Office of Compliance, CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), FDA

Prioritize Oversight Activities With a Risk-Based Approach Resulting in a Continual Inspection-Ready State - Michael Torok, Ph.D., Clinical Quality Assurance Head, ASTELLAS

Demonstrate the Steps for Defining and Implementing Appropriate Quality Tolerance Limits (QTLs) Through Case Study Examples - Jonathan Rowe, Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER Stacy St. John, Director, Clinical Development Quality, GCP Quality Management Lead, PFIZER

Effectively Respond to Noncompliance With the Proper Development and Execution of Corrective and Preventive Actions (CAPAs) - Sheila Gwizdak, MS, Vice President, Quality, HALLORAN CONSULTING GROUP Kathy Goldstein, Senior Director, Quality Management Lead, REGENERON PHARMACEUTICALS