Corrective and Preventative Action Topics: Investigation Phase, Action Phase and Verification of Effectiveness Phase

This two-day hands-on workshop utilizes a teach-do-teach-do approach that keeps participants engaged throughout the course. Many real CAPA examples are presented. CAPA owners are often challenged with understanding how to utilize data analysis tools during the investigation phase. This workshop explains when and how to apply many of the common analysis tools necessary to conduct effective CAPA investigations. Additionally, the course demonstrates methods to scope CAPAs and to develop robust CAPA verification of effectiveness plans utilizing risk-based sampling to ensure CAPA effectiveness is confirmed with a high degree of confidence.

The CAPA Workshop focuses on the three phases of CAPA: Investigation Phase, Action Phase and Verification of Effectiveness Phase. A manufacturing case study is utilized where participants work in teams, following a problem-solving methodology, to identify root cause, brainstorm possible actions, and develop a verification of effectiveness plan. The workshop provides examples of how to document the various CAPA phases. Good and poor examples are presented along the way. Participants find this particularly useful as a reference when documenting their own CAPAs.