Regulators expect you to have a world-class quality management system (QMS) that goes beyond simple compliance to achieve continuous improvement and an active quality culture.

Save the date for the FDAnews GMP Quality Management vSummit 2023, taking place virtually Oct. 11-12. You’ll hear from top industry experts on developing a world-class QMS that uses the most up-to-date good manufacturing practices to ensure:

  • Your products are both effective and safe
  • Your products meet the quality expectation of consumers
  • Your products are completely free of any contamination and defects
  • Your patients are completely confident that their treatment and care are world-class

The program will include sessions for medical devices, pharmaceuticals, and combination products including:

  • CDER’s Quality Management Maturity Initiative
  • CDRH’s Case for Quality
  • The upcoming Quality Management Systems Regulation
  • Combination Product Risk Management
  • Ensuring Vendor Quality
  • Building a Culture of Quality
  • And much more

Meet Your Summit Chairperson

Steven Lynn

Steven Lynn
Executive Consultant, Pharma Compliance
Regulatory Compliance Associates

Steven Lynn, executive vice president of pharmaceuticals for Regulatory Compliance Associates (RCA), has more than 25 years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma and tissue industries. Joining RCA in September 2020, Lynn 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.