CAP and CLIA Requirements for Clinical Research Laboratories May 2019

May 1, 2019
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Course Description

This web seminar will provide a general overview of the College of American Pathologists (CAP) and Clinical Laboratory Improvements Amendments (CLIA) requirements for laboratories that perform routine and non-routine testing of clinical samples for clinical trials. We will review the laboratory requirements for patient care and the requirements for clinical research. Similarities and differences of CAP requirements from ISO 15189 Medical Laboratories Requirements for Quality and Compliance, as applicable, will be discussed. This web seminar provides training for the auditor/inspector assessing clinical laboratories for compliance.

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Learning Objectives

  • Describe CAP/CLIA’s goals to patient safety and privacy
  • Describe the general CAP/CLIA requirements
  • Distinguish similarities and differences of laboratory requirements from CAP and ISO 15189
  • Identify inspection and/or audit a laboratory’s compliance to CAP/CLIA

Who Should Attend

  • Auditors
  • Regulatory Agency Inspectors
  • Laboratory Managers/Directors
  • Laboratory Quality Professionals

Instructor

Suzi Tran, M.B.A., CMQ/OE, CQA, CSQE

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.