1 Hour and 15 Minute Webinar Recording
Speaker
Casper E. Uldriks, JD, MDiv.
Associate Center Director Regulatory Guidance and Government Affairs
Center for Devices and Radiological Health
FDA
When it comes to possible health risks, transparency and cooperation with regulatory bodies is of utmost importance. Many manufacturers are confused about what to report to the FDA. What exactly does "significant" mean when it comes to MDR? Hear from an FDA expert on:
- Relevant Contact Within the Agency
-How to properly report
-Adverse events
-Design malfunction
-Packaging/Sterilization errors
- How to Prepare for a Subsequent Audit, Warning, or Recall
About the Speaker
Casper E. Uldriks is the Associate Director for Regulatory Guidance and Government Affairs at the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). He manages the implementation of the Federal Food, Drug, and Cosmetic Act, as amended, for medical devices and the development of guidance and regulations for the agency's device program. He is recognized as FDA's expert in the interpretation and application of several statutory provisions.
Cost
The cost to purchase the video recording is $395.
Once your order is processed you will shipped a copy of the video file on flash drive. The video comes in windows media format and can easily be played on your computer.
Check out a sample of the video here
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