Original Audio Conference Date: October 30, 2008

90 Minute Audio Recording

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? Here from an FDA expert on:

• Relevant contacts within the agency
  • How to properly report
  • Adverse events
  • Design malfunction
  • Packaging/Sterilization errors
• How to prepare from a subsequent audit, warning, or recall
  

Casper E. Uldriks, JD, MDiv.
Regulatory Health Scientist
Center for Devices and Radiological Health
FDA

Speaker Biography

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

$395 Includes the 90 minute recording in mp3. format and presentation slides