Course Description

This web seminar will provide an introduction to 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 is an introductory course and not intended for experienced users.

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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

• Laboratory Staff new to CAP and CLIA
• Auditors
• Regulatory Agency Inspectors
• Laboratory Managers/Directors
• Laboratory Quality Professionals

Instructor

Shelia Russell McCullers, M.S., D.M.

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