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Live Webinar Laboratory Developed Tests under FDA's Thumb Date: Tuesday, March 10, 2015 Instructor: Casper Uldriks
Time: 10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
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Location: Online
Overview: The webinar clarifies the regulatory concern that FDA has and whether subjecting Laboratory Developed Tests (LDTs) to FDA's device Quality System Regulation can make a measurable difference in the safety and effectiveness (reliability) of special IVDs. The arguments on both sides of the issue will be identified and how regulation may adversely impact the quality of health care we have today. The presumption by FDA is that regulation will improve these special IVDs and, thereby, improve the quality of health care.
Areas covered in the session: Reasons for FDA regulation Applicable regulations Use and availability of LDTs Identify logistical risks Steps for implementation
Who Will Benefit: Clinical laboratories Pathology practice groups Medical institutions (hospitals) using Laboratory Developed Tests Practitioners Healthcare maintenance organizations Medical device and diagnostic manufactures Risk managers for healthcare practices Regulatory affairs managers for IVD manufacturers Cost control consultants for healthcare practices
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About Speaker Casper Uldriks ex-FDA Expert and former Associate Center Director of CDRH, Olsson Casper Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as 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 is recognized as an exceptional and energetic speaker. His comments are candid, straight forward and of
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