CAP and CLIA Requirements for Clinical Research Laboratories

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. 

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.

Click here for complete trainer biographies

Registration Fees

$835

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-23-051-L99-P. Released: 5/23. 

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