Course Dates Upcoming Dates and Locations Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times. There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!
Course Details What You Will Learn At the conclusion of this workshop, you will be able to: Explain CAPA methodology, including roles, inputs, and metrics/sources of data. Learn best practices for how to integrate your CAPA program into your quality system. Understand FDA’s and other regulatory officials’ expectations for “what CAPA is” and the steps required to get you there. Learn how CAPA can positively impact the bottom line. Understand how to differentiate and document known problems versus identifying those problems that require further investigation and CAPA. Develop a risk-based approach to the CAPA process to determine the depth of investigation, CAPA cycle time, and any immediate corrections your organization needs to take. Perform basic root cause analysis, including problem definition and effectiveness checks. Who Should Attend Recommended for management, and staff in compliance/regulatory affairs, QA/QC, manufacturing operation, and document management. Virtual Class Days 4 Consecutive half-day sessions. Daily sessions run from 1:00-5:00 p.m. Eastern time. Virtual Half-Days In-Person Full-Days CEUs 1.5
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