Breakout

Breakout # 2: Quality beyond the factory’s walls: Managing Supplier Risk and Quality From Off-the-Shelf to Custom Contract Manufactured Products

Thursday, April 23, 2026

1:30pm - 3:00pm East Coast USA Time

Moderator(s)

GB

Gina Bracket

Assistant Director, Establishment Assessment Team 1, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA (Invited)
John Krug

Executive Director and Site Quality Leader of Indianapolis Device Manufacturing
Eli Lilly and Company
Susan Matthias

Consumer Safety Officer, Special Assistant, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
FDA (Invited)

The manufacture of medical devices is increasingly reliant on distributed value chains, with manufacturing steps of varying complexity (ranging from off the shelf raw materials to full custom contract manufacturing of finished devices) outsourced to suppliers. This 90 minute session will clarify the regulatory requirements for supplier risk and quality management. Industry experts will describe successful strategies for satisfying these requirements while enabling the manufacture of high quality medical devices to meet market needs.