According to the FDA (as well as other regulators), CAPA management and lack of proper investigation of challenges is a top observation among companies in the industry. This short course will demonstrate by using interactive case study sessions how to perform a proper investigation into a robust root cause analysis using industry standard tools, in a toolkit approach. Also, challenges will be presented of proper CAPA planning and defining appropriate effectiveness checks to ensure these observations do not occur again and how to properly document what was performed. We will use direct case studies from various FDA 483s to show real-life situations on how to apply our toolkit approach to avoid action by regulators and ensure compliance in your processes and company culture.
At the conclusion of this short course, participants should be able to:
- Describe and train individuals on best industry practices in CAPA management
- Recognize how to utilize proven tools, in a toolkit format, to properly investigate observations and formulate robust CAPA plans and effectiveness checks to ensure compliance and remediation of observations
- Discuss case studies that will help solidify use of tools.