Senior Advisor, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
FDA
Karen Masley-Joseph has 24 years of experience at FDA, in investigations, compliance, quality management system implementation and leadership roles. As the Senior Advisor for FDA’s device inspectorate, she collaborated with CDRH as the lead for OII’s implementation of the Quality Management System Regulation (QMSR). Karen is an ISO 13485 certified lead auditor. She holds a B.S. in Chemical Engineering and an MBA from Northwestern University and served in the US Peace Corps.
Thursday, April 23, 2026
8:10 AM - 8:45 AM East Coast USA Time
Updated Compliance Program (CP) for Inspection of Medical Device Manufacturers
Thursday, April 23, 2026
8:45 AM - 10:10 AM East Coast USA Time