Introduction to Root Cause Investigation for CAPA 2019

Topics

• FDA and ISO (13485) Requirements
• What is CAPA vs Correction
• Steps in a CAPA Process
• CAPA’s Criticality in Quality Systems
• Risk Management as Part of CAPA
• Quality Data Sources for CAPA
• Challenges Associated to RCA
• What is a Root Cause Analysis (RCA)/Investigation
• Six Steps in Problem Solving
• Difference between a direct cause, a contributing cause and a true root cause
• Tools Used for RCA/Investigation
• Steps to Follow If the Root Cause is Not Clearly Known
• Examples of Three of These Tools and When to Use Them

Who should Attend

• Quality Assurance/ Quality Control Personnel
• CAPA Owners
• Document Control Personnel
• Regulatory Compliance Professionals
• Quality and Manufacturing Engineer
• Regulatory Affairs Professionals
• Quality Auditors
• Supplier Quality Managers