Implementing an Effective CAPA System

[Adam Fleming]

CAPA, no matter how you look at it, is the heart of the quality management system. CAPA can be viewed as and is the merging of change control, continuous improvement, and complaint management.

What does the CAPA system do for the organization? CAPA not only indicates the organization's ability to respond to problems that arise but also to proactively anticipate and prevent subsequent problems from arising.

This webinar highlights the various regulations governing CAPAs, how CAPAs are successfully initiated and managed, how CAPA is an integral part of the quality system, and how an effective failure investigation and root cause analysis is accomplished. During this webinar, emphasis is placed on the application and practical aspects of the process to include its critical steps, CAPA timing, participants to the process, roles and functions, and the pitfalls associated with CAPA investigations.

The content of the webinar will focus on the practical and how to best thoroughly accomplish an effective CAPA system. At the completion of this webinar, you will be able to:

• Explain the purpose and function of CAPA
• Identify and explain the relevant CAPA regulations
• Define exception/deviation reporting and explain the process of executing the reporting process
• Explain and trace the CAPA flow from problem identification to resolution
• Explain the challenges and pitfalls of the CAPA process and how they are overcome
• Explain CAPA's role in risk mitigation
• Explain how root cause analysis is executed