Medical Device CAPA Training: Optimizing Your Programs

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.

Number of Days: 2
CEUs: 1.5

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