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Recorded WebinarNew

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

Cut through recurring FDA registration, listing, and facility licensing errors — avoid misclassifications, missed updates, and common pitfalls under 21 CFR Part 807 and Part 820.

4.8(0 reviews)
1.5 hours
Meredith Crabtree

Instructor

Meredith Crabtree

GMP Quality Consultant & Validation Specialist

What You'll Learn

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

About This Event

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. 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, and helps teams avoid common traps under 21 CFR Part 807 and Part 820. Code: FDB1413

Curriculum

Registration and Listing Scope Across Products, Sites, and Operations
12 min
Facility Licensing Triggers, Timing, and Common Misclassifications
12 min
Change Management for Updates, Renewals, and Discontinuations
12 min

Requirements

  • QA, Regulatory Affairs, Manufacturing, and Operations professionals
  • Applicable to supply chain, contract manufacturing oversight, and compliance teams

Meet Your Instructor

Meredith Crabtree

Meredith Crabtree

GMP Quality Consultant & Validation Specialist

Meredith Crabtree has over 30 years' experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting and specializes in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.

30+ Years GMP ExperienceIQ/OQ/PQ SpecialistConsent Decree SupportMulti-Industry QA Expert
Quantity
1

Recording – 1 Viewer

$350.00
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Certificate of completion

Event Details

Format

Recorded Webinar

Duration

1.5 hours

Certificate

Included

Access

Lifetime

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