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. UDI and GUDID requirements are addressed in context, showing how they fit into day-to-day quality operations rather than existing as a separate regulatory burden.

If you work in QA, RA, manufacturing, engineering, or document control, this session closes the gap between “knowing the regulation” and running a labeling system that holds up under scrutiny. You’ll walk away with a clearer view of how to prevent labeling errors, reduce recall risk, and maintain control across product categories — without over-engineering your processes.

AGENDA:

• FDA medical product labeling requirements under 21 CFR 801 and their GMP implications
• Labeling control within quality systems, including linkage to DMR and batch records (21 CFR 820 / 211)
• Types of Labeling: Equipment, Control, Package, Directions of Use, Maintenance Manual, Electronic Message Panels
• Understanding misbranding risk and enforcement triggers under FD&C Act Section 502
• Labeling requirements across product categories: devices, pharmaceuticals, OTCs, supplements, and IDEs
• UDI framework, submission expectations, and compliance under GUDID
• Managing labeling operations: content accuracy, legibility, placement, and line clearance controls
• Integrating labeling compliance into audits, inspections, and recall prevention strategies

WHO SHOULD ATTEND:

This webinar will provide valuable assistance to all regulated companies that need to review and modify their labeling and/or labeling procedures. It will address general as well as specific requirements of medical devices, pharmaceutical, diagnostic, and biologics / human tissue fields. The employees from these department will benefit most:

• Quality Assurance Departments
• Research and Development Departments
• Regulatory Affairs Departments
• Production Departments
• Engineering Departments
• Manufacturing Departments
• Document Control Specialists