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.
This workshop will teach:
How to conduct CAPA investigations
How to understand the goals of the investigation
How to define, measure, and scope the problem
How to determine the potential causes
How to eliminate potential causes to identify the Root Cause(s)
How to apply Capability Optimization:
Target Performance/Reduce Variation
The goals of Verification Of Implementation (VOI)
The goals of Verification of Effectiveness (VOE) and its relationship to Verification & Validation (V&V)
Applications of Risk-Based Sampling Plans
Confidence & Conformance
Population vs. Sample
How to plan and execute a VOE