155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach
Laurie Auerbach, President of Compliance Prodigies, LLC, explains FDA Compliance Program 7356.000, clarifying that contract manufacturers (CMOs) and component suppliers selling bundled solutions are legally defined as combination product manufacturers. She highlights common failures in mock Pre-Approval Inspections (PAIs), particularly the misconception that drug GMPs (21 CFR 211) and ICH Q10 fully satisfy device requirements under 21 CFR Part 4. Auerbach emphasizes that sponsors often fail to audit suppliers for device-specific elements like design control, risk management, and specific supplier controls, leading to critical gaps in quality agreements and inspection readiness.