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This webinar provides biomedical diagnostics professionals with a comprehensive overview of the FDA's landmark final rule on Laboratory Developed Tests (LDTs) and its transformative impact on the regulatory landscape for diagnostic laboratories. Learn about quality system requirements (QSR), key compliance deadlines, and actionable strategies to improve quality, increase effectiveness, reduce costs, and prepare for the phase-out of enforcement discretion. The expert panel featuring Michael J. Donovan, Ph.D., JD, Travis Schlappi, PhD, and Mara G. Aspinall, MBA clarifies the FDA's quality system requirements and highlights potential global implications of these regulatory changes. Gain valuable insights into the impact on clinical laboratory operations, including ISO 15189 and ISO 13485 considerations, registration and labeling mandates, and premarket review timelines. Designed for laboratory directors, regulatory affairs specialists, and diagnostics manufacturers, this 45-minute session equips you with essential knowledge to improve quality systems and navigate the new compliance landscape in turbulent times. PACE credits available until April 3, 2027.
