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Speaker Profile
CASPER ULDRIKS

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s food and medical device programs as a field investigator, served as a senior manager in the Office of Compliance, and as an Associate Center Director for regulatory guidance and government operations. He developed enforcement actions and participated in the implementation of new statutory requirements, such as FDA’s import/export program. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward, and practical value. He understands how the FDA thinks, operates, and where it is headed. Cap is the President of Encore Insight, LLC, a consulting service for FDA matters.


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$200.00
EU Medical Devices Regulation: CE Mark Expiration and the EU Refusal of Your Exports

 Casper Uldriks
 Recorded Webinar
 60 Minutes
 Download Catalog
EU Medical Devices Regulation: CE Mark Expiration and the EU Refusal of Your Exports

FDA and the EU have tried to harmonize device regulatory requirements for over 25 years. Major differences between the FDA and the EUincludepremarket authorization (CE Mark), complaint investigations, postmarket surveillance, and reports. The EU’s new Medical Devices Regulation (MDR) incorporates more rigorous regulatory requirements for those areas and in some cases outpaces the FDA’s requirements. The FDA..

$200.00
Managing an FDA Foreign Inspection

 Casper Uldriks
 Recorded Webinar
 60 Minutes
 Download Catalog
Managing an FDA Foreign Inspection

Agreeing to an FDA foreign inspection requires careful preparation on a firm’s part. If you do not manage your inspection wisely, you will set yourself up for disaster. We will cover fundamental issues, such as pre-inspection tasks, preparing your documents and having an interpreter before, during and after the inspection. We will also address how you should respond to inspectional problems noted by the FDA..

$200.00
The Risks Embedded in Using Social Media for Product Promotion

 Casper Uldriks
 Recorded Webinar
 60 Minutes
 Download Catalog
The Risks Embedded in Using Social Media for Product Promotion

What a firm can say in social media and what an individual can say, are two different worlds, but it is easy to jump unknowingly from the individual to the corporate world of what is legally acceptable to FDA. Firms need to extrapolate corporate boundaries for how they can use and not use social media. What a firm says and how firms deliver a message are equally laden with risk. And ripe for FDA’S administr..

Showing 1 to 3 of 3 (1 Pages)