FDA Labeling and UDI Essentials for Medical Products

Description

This course clarifies how FDA labeling and UDI requirements truly work in practice — turning 21 CFR rules into a clear, controllable labeling system that reduces misbranding risk, inspection findings, and costly rework across medical products.

Labeling is one of the fastest ways for medical products to fail an FDA inspection. Not because teams don’t try — but because labeling rules quietly cut across quality systems, manufacturing, documentation, and post-market control. This webinar brings clarity to what FDA actually expects when it comes to labeling content, control, execution, and traceability across medical devices and pharmaceuticals.

The session connects labeling requirements directly to GMP realities. You’ll see how labeling ties back to the device master record, batch documentation, line clearance, inspection readiness, and misbranding risk. Beyond packaging labels, the discussion extends to IFUs, maintenance manuals, control labels, electronic displays, and system-generated instructions — all areas FDA increasingly reviews during inspections.