September
22
2021
12:00pm - 10:10pm EDT
Past Event

Event Description

Join us for our next OneLab Network meeting to learn more about Emergency Use Authorizations (EUAs). This session will focus on how a test life cycle differs from that of the typical life cycle along with events that occurred during the COVID-19 emergency response. Presentation topics will include:

  • Modifying manufacturing procedures when using EUAs
  • Supply shortage of testing materials
  • Interpreting tests when using EUAs
  • Diagnostic testing compliance during emergency responses

We will be joined by a panel of representatives from the U.S. Food and Drug Administration, the Centers for Medicare & Medicaid Services, and Quest Diagnostics. The panel will lead the discussion and participate in a Q&A session.

This session is appropriate for all OneLab Network members who support test performance management in their organizations or provide test verification-related education and training to staff related to test verification.

Event Media

Play Audio

Read the Audio Transcript!
graphical user interface, text, application

Event Speakers

Michael J. Wagner

Michael J. Wagner, Esq.

Corporate Counsel

Legal Department Quest Diagnostics Incorporated

Christine Sabol

Christine Sabol CG (ASCP) CM , CCS, CPC

Medical Operations & Regulations Legal

Department Quest Diagnostics Incorporated

Toby Lowe

Toby Lowe

Associate Director for Regulatory Programs in OHT7

Office of In Vitro Diagnostics and Radiological Health (OIR)

Office of Product Evaluation and Quality (OPEQ)

Center for Devices and Radiological Health (CDRH)

U.S. Food and Drug Administration (FDA)

Monique Spruill

Monique Spruill

Director Division of Clinical Laboratory Improvement and Quality (DCLIQ)

Quality, Safety, and Oversight Group (QSOG)

Centers for Medicare & Medicaid Services (CMS)