LDT Foundations: Standards to Prepare for Stage 1 Requirements
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Agenda
Introduction and General Updates | Shannon Bennett, MS, MBA, CMQOE(ASQ)
Guidance for Stage 1 | Christopher Dailey, PhD
Two Important CLSI Guidelines for LDTs: QMS11 and QMS18 | Lucia Berte, MA, MT(ASCP)SBB,DLM,CQA(ASQ)CMQ/OE
Panel Discussion
Learning Objectives
- Describe three steps you can take to prepare for stage 1 of the FDA's Final Rule on Laboratory Developed Tests (LDTs).
- Identify two resources that your laboratory can use to prepare for stage 1 of the ruling.
Earn 1.0 P.A.C.E. credits for this on-demand webinar.
CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.
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Two Important Guidelines for LDTs: QMS 11 and QMS18
Open to view video. | 17 minutes
Open to view video. | 17 minutes
