FDA Labeling and UDI Essentials for Medical Products

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

Course Director: José Mora

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under José’’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.