Responding to FDA Enforcement Actions - 483s and Warning Letters

Remediation Services

Whether your organization has audit findings/observations from official regulated body audits, internal audits or UL mock audits, UL remediation services can provide consultation and support to create and implement remediation plans for all findings allowing you to provide the required response and updates to regulatory agencies and successfully remediate all findings before subsequent re-inspections.  The workshop will also assist you to write objective and logical responses to observations/audit findings and recommendations for corrective and preventative actions. 

 

Contact UL EduNeering's Advisory Services team at 609.627.5300 or email EduNeeringInquiry@UL.com to learn more.

  • UL EduNeering's Partnership with FDA Extended Until 2019

    The FDA's Cooperative Research and Development Agreement (CRADA) with UL EduNeering has created a collaborative partnership between the two organizations, resulting in courses developed with, and used by FDA inspectors and industry professionals worldwide.

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  • UL EduNeering maintains an Exclusive Compliance Partnership with AdvaMed

    UL serves as AdvaMed's exclusive online compliance partner, providing its members with educational resources to maintain regulatory compliance and professional knowledge. Those programs accommodate the needs of both emerging companies and well-established device firms.

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  • Brandon Hall Excellence in Technology Awards

    For SIX years running, UL has won an Excellence in Technology Award from Brandon Hall.  These awards were presented by Brandon Hall Research, one of the leading research firms in training and development.

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