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Seminars
Claims Substantiation Seminar
This two-hour training will be a scientific dive into the regulatory requirement of claims substantiation. Several topics including the following will be discussed along with real case examples: which types of evidence are available and where to find them; what are high quality and low quality evidence; when is the evidence irrelevant to the claim being made; and how to write claims that can be substantiated.
Webinars
Medical Device QMSR (ISO 13485)
Presented by Jeb HunterDecember 15, 2025 | 1 PM EasternIn January of 2024, 21 CFR 820 was harmonized with ISO 13485 into the Quality Management System Regulation (QMSR), a regulation that better aligns the processes and requirements for a medical device facility with...
On Demand Webinars
How to Respond to an FDA Inspection (483)
Now that the FDA has issued your firm a 483 or Warning Letter, what to do next? This webinar will cover the expectations and requirements of the FDA for responding to inspectional findings, best practices, and tips for creating a comprehensive response, including corrective and preventive actions taken and planned to address the observations.