In this two-day session, learn the basics of creating a corrective and preventative action (CAPA) plan, how to apply the CAPA process to an actual audit finding, hear from three Stanford experts actively involved in CAPA work, and put your newly acquired knowledge into practice by creating a CAPA for an actual audit finding. Attendance at day one is a pre-requisite to attending day two.
Day one (May 3) will include
· A didactic presentation on Corrective and Preventive Action (CAPA) processes,
· Presentations describing CAPA programs from three Stanford Medicine entities currently doing CAPA work: Clinical Research Quality (CRQ), the Cancer Clinical Trials Office (CCTO), and the Stanford Center for Clinical Research (SCCR),
· A demonstration of how to apply the CAPA process to an actual audit finding, and
· A panel discussion.
Day two (May 10) will be a working session to apply the knowledge acquired on day one. Participants will break into groups and work with a facilitator to create a CAPA for an actual audit finding.
Dates: Wednesdays, May 3 & 10, 2023
Time: 9:00 - 11:00 am
Location: Virtual seminar. Enroll, return to the course website to participate in learning components. This class will take place LIVE via zoom meeting.
**To achieve a certificate, you must attend BOTH classes and complete the quiz and evaluation for each session.
Clinical Research Professional Competency: Clinical Trials Operations (GCPs)
*This is an elective in the Clinical Research Operations Program.
OPTIONAL - BRN Credit
Spectrum is an approved provider by the California Board of Registered Nursing, Provider Number CEP15435 for 4.0 contact hour(s). If you would like to receive credit for attending this class, on the evaluation, please add your employee ID and acknowledge fee on evaluation. A $35 administrative fee will be charged to your STAP. You will be required to complete the quiz and evaluation before receiving your certificate of attendance.
BRN CANCELLATION POLICY: If you need to cancel, please do so within 24 hours of the course date or notify firstname.lastname@example.org to receive a refund.