This trainer-led course provides an overview of the regulations and guidance relating to Corrective And Preventative Actions (CAPA) and Root Cause Investigations for medical devices manufacturing, explores CAPA system requirements, Event Investigation Flow within the CAPA process and CAPA Effectiveness, including the use of process monitoring and AQL and c=0 sampling approaches.
It also sets out a risk-based approach to the root cause analysis process in line with ICH Q9. Techniques and tools for the analysis of situations and events that require root cause analysis are examined to provide a structured and comprehensive approach. Participants apply their learning through consideration of case studies based on real world scenarios.
The regulatory requirements and key concepts of CAPA, including CAPA System Requirements and Event Investigation Flow and Root Cause Investigation followed by a detailed exploration of the tools and techniques for root cause analysis e.g., Cause and Effect, 5 Whys, Walk through and Variance analysis. CAPA Effectiveness is also explored including the use of performance monitoring, AQL and C=0 sampling methodologies. The exploration of real-world scenarios from event to resolution is an important element of the course.