Quality and Compliance from the Regulators’ Perspective

  • What are regulators looking for when they engage with QA/QC executives and other senior leaders? How can industry facilitate these interactions?
  • Thinking about your processes and facilities from the point of view of the inspector: What are you taking for granted based on familiarity or habit or tradition that would not apply to a fresh pair of eyes?
  • Highlighting best practices to make ongoing documentation a powerful quality and compliance tool for the future
  • Using compliance as a starting point: What does exceeding expectations look like, and how should pharmaceutical manufacturers stay ahead of that moving target in perpetuity?

Peter Marks
Director – Center for Biologics Evaluation and Research (CBER)

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.