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

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

Vanessa Lopez
Sr Quality Regulatory Consultant, Quality and Regulatory Consulting Services

Ms. Lopez has held a wide variety of leadership roles in the Medical Device (Class: I, II, and III), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as the Consulting Services industry. She has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly, Pall LifeSciences, among others. She possesses over 25 years of experience focused on development, implementation, driving improvements and monitoring of Quality Assurance, Quality Control, Regulatory Compliance, Regulatory Affairs, Quality Systems and Supplier Quality activities. Ms. Lopez has in-depth knowledge, coaches on interpretation and application of US regulations, EU directives, specific country regulations (Japan, Canada, and others), national/international standards and guidance documents. She has also held positions within the CAPA, Material, Safety and Management Review Boards as well as represented Quality in Design Control phases.

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