← Back to Catalog
Live WebinarNew
Design Changes After Clearance: When a New 510(k) Is Required
4.8(0 reviews)
1.5 hoursFriday, October 9, 2026Instructor
What You'll Learn
About This Event
Curriculum
Requirements
Meet Your Instructor
Event Details
Format
Live Webinar
Duration
1.5 hours
Certificate
Included
Date
Friday, October 9, 2026
Topics
Related Events
Live WebinarNew-24%
Regulatory & ComplianceCertificate
AI in GMP: What the FDA Is Already Expecting - Before You Ask
FDA already expects GMP compliance for AI systems. Learn how existing validation, data integrity, and oversight rules apply—before regulators come calling.
Dr. Ginette Collazo1.5 hoursJun 30, 2026
4.8
from$190.00$250.00
Live WebinarNew
Regulatory & ComplianceCertificate
The First FDA Warning Letter on AI: What It Means for Your Quality System
The FDA issued its first AI-related Warning Letter. Learn what it means for your QMS, validation requirements, and how to keep your quality systems inspection-ready.
Dr. Ginette Collazo1 hourJul 1, 2026
4.9
from$145.00
Live WebinarNew
Regulatory & ComplianceCertificate
Digital Quality Metrics and AI/ML Analytics: Building a Continuous-Improvement Framework that Aligns with Regulatory Expectations
Learn how AI/ML and real-time digital quality metrics build a continuous-improvement framework aligned with FDA regulatory expectations, 21 CFR Part 11, and GAMP®5.
Carolyn Troiano1.5 hoursJun 18, 2026
4.9
from$145.00