FDA Registration, Listing & Facility Licensing - Common Pitfalls and Best Practices

This course cuts through recurring FDA registration, listing, and facility licensing errors that delay approvals and trigger avoidable findings, translating regulatory requirements into clear, defensible actions. It sharpens decision-making across product types and operations so teams register correctly, maintain alignment, and withstand inspection scrutiny with confidence.

WHY YOU SHOULD ATTEND:

Registration, listing, and facility licensing seem straightforward, yet teams routinely struggle with scope decisions, timing, and ownership across products, sites, and changes. Multi-product portfolios, contract relationships, and evolving operations amplify the complexity.

Where organizations go wrong is assuming guidance equals execution. Misaligned product classifications, incomplete listings, missed updates, and unclear responsibilities surface during inspections, enforcement actions, and downstream submissions—often long after the error was made.

This webinar delivers practical clarity on how FDA expects registrations, listings, and licenses to be established and maintained. It strengthens judgment around gray areas, helps teams avoid common traps, and supports defensible decisions that hold up under audit and inspection pressure.

AREAS COVERED:

• Registration and listing scope across products, sites, and operations
• Facility licensing triggers and timing considerations
• Common misclassifications and their downstream impact
• Change management for updates, renewals, and discontinuations
• FDA inspection focus areas and typical findings
• Coordination across internal teams and external partners
• Regulatory expectations under 21 CFR Part 807 and Part 820

WHO SHOULD ATTEND:

• Quality Assurance (QA) Departments
• Regulatory Affairs (RA) Departments
• Manufacturing Departments
• Operations Departments
• Supply Chain and Distribution Leaders
• Labeling and Packaging Departments
• Contract Manufacturing Oversight Teams
• Compliance and Inspection Readiness Leads
• Site and Facility Management Leadership

Course Director: MEREDITH CRABTREE

Meredith Crabtree brings over 30 years of hands-on regulatory and quality experience across blood, plasma, pharma, medical devices, cosmetics, supplements, and animal health. As Principal of MLKC Consulting, she supports FDA registrations, label reviews, third-party inspections, consent decree remediation, recalls, and regulatory assessments—grounded in real inspection and enforcement realities.