Introduction to Root Cause Investigation for CAPA

Why Should You Attend:

If you have reoccurring problems showing up in your quality systems, your CAPA system is not effective and you have not performed an in-depth root cause analysis to be able to detect through proper problem solving tools and quality data sources, the true root cause of your problem. Unless you can get to the true root cause of a failure, nonconformity, defect or other undesirable situation, your CAPA system will not be successful. Historically, 483s in the medical device industry related to CAPAs, are due to lack of inadequate root cause investigations, among other factors. This course focuses on the medical device industry and provides a basic understanding on:

1. What are the FDA and ISO (13485:2016) requirements
2. How is root cause analysis integrated into the CAPA process and risk management
3. Challenges associated to root cause analysis
4. Problem solving tools to use during the root cause analysis investigation
5. Where to find objective evidence for this type of analysis

Learning Objectives:

• Understand the difference between a correction, corrective action and preventive action
• Learn which medical device regulation and standard, apply to CAPA
• Learn why root cause analysis is important
• Understand the difference between a direct cause, a contributing cause and a true root cause
• When to use root cause analysis during the CAPA process
• Understand the association between root cause and risk management
• Tools and quality data sources you may use during root cause analysis

Areas Covered in the Webinar:

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

Who Will Benefit:

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