
Steven Lynn, executive vice president of pharmaceuticals for Regulatory Compliance Associates (RCA), has more than 20 years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma and tissue industries. Joining RCA in September 2020, Steven serves as executive vice president of pharmaceuticals. Prior to joining RCA, he served in executive leadership roles with global accountability in the private sector as well as at the FDA. While at the agency, he was the director of CDER’s Office of Manufacturing and Product Quality. In this role, he was responsible for the global oversight of all drugs manufactured and/or imported into the U.S. In addition, in his last year at the FDA, he also served as the operations transition lead for CDER’s new Office of Pharmaceutical Quality.
Breakout 1: CDER’s Quality Plan
Quality Metrics: Essential to Quality
Ensuring Continuous Improvement: Essential to Quality
Dealing with Real-Life Scenarios
First Day Wrap-Up
Welcome to Day 2
Industry Efforts to Improve Quality Management: Success Stories
Risk Management: Essential to Quality
Establishing a World-Class Culture: Essential to Quality
Summit Wrap-Up