CAPA for Nonconformities


Lesson Code: OPE-1101 (PREMIUM LESSON). An overview of the key concepts and terminologies associated with nonconformities, and the CAPA methodology used to address them as part of a company’s Quality System. Using a scenario-driven approach, the user is taken through the key steps of a CAPA process from identifying a problem to verifying the effectiveness of the solutions implemented to resolve it. In doing so, users will be better equipped to distinguish between corrections, corrective actions, and preventive actions. The concept of risk and categorization of nonconformities as minor, major, or critical is also covered as are regulatory expectations surrounding nonconformities and CAPA.


  • Category: CAPA

Description

Operational Excellence: Nonconformities and CAPA

This module is aimed at personnel in regulated manufacturing facilities, who are typically involved in CAPA-related activities, e.g. personnel in production, quality, engineering, facilities, maintenance, etc.

The module uses a scenario-rich design to introduce the user to the key concepts and terminologies of CAPA. Using various industry-based scenarios, the user will be taken through the key steps of a CAPA process from identifying a problem to verifying the effectiveness of the solutions implemented to resolve it. In doing so, users will be better equipped to distinguish between key concepts such as corrections, corrective actions, and preventive actions. They will also work through the concept of risk, categorization of nonconformities as minor, major, or critical, and subsequent decision-making regarding CAPA implementation. The regulatory expectations surrounding nonconformities and CAPA will also be stressed.

Key benefits:

  • Gain enhanced understanding of the different terminologies associated with CAPA.
  • Distinguish between terms such as correction, corrective action and preventive action.
  • Explore the concept of risk and categorization of nonconformities as minor, major, or critical.
  • Practice the decision-making associated with CAPA initiation.
  • Avoid mistakes commonly associated with CAPA.
  • Gain clarity on regulatory expectations.

Check out these sample screens from the Lesson:








Download the Product Sheet with additional info and contact details:

Europe:

EU_CAPA Product Sheet.pdf

USA:

US_CAPA Product Sheet.pdf