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.
This timely program will teach you to:
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
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...
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