FDA’s Post-Market Surveillance Enforcement for Medical Devices

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, May 15, 2018
60 minutes
Product Description

Leverage Your TPLC to Self-Correct

The U.S. Food and Drug Administration (FDA) is reorganizing its pre-market and post-market offices in the Center for Devices and Radiological Health (CDRH). What does this mean for your company? Expect a major impact on your use of Total Product Life Cycle (TPLC) and third-party programs, which may pave the way to a less-threatening enforcement landscape with the FDA – if you play your cards right.

Learn how to make the most of the agency’s reorganization in this information-packed audio presentation by FDA expert Casper Uldricks. Specifically, he will walk you through the critical elements of the FDA’s post-market surveillance program for medical devices. You’ll learn the details of the FDA’s focus on the TPLC paradigm—and how your corrective and preventive actions will receive more scrutiny as a result.

After attending this audio event, you will have the tools and knowledge you need for better coordination between compliance programs and pre-market programs. You’ll be able to interact more effectively and efficiently with the FDA, and you’ll know the steps to take (now!) regarding post-market surveillance that will make a significant difference in your regulatory options and enforcement-action prevention.

Session Highlights

This timely program will teach you to:

  • Leverage your TPLC to carry out self-corrective actions for post-market problems.
  • Understand the intricacies of the CDRH reorganization and discover more effective TPLC implementation strategies.
  • Use voluntary standards and self-affirmation of conformance to meet your product clearance requirements.
  • Develop a quality assurance track record that will ease the FDA’s post-market surveillance crackdown on your company.

Who Should Attend

  • Regulatory affairs directors
  • Quality assurance directors
  • Quality Control directors
  • Corporate business plan managers
  • Recall and corrective action managers

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Casper E. Uldriks

 Casper (Cap) Uldriks brings over 32 years of experience from the FDA.  He specializes in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He...   More Info
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