Introduction to Root Cause Investigation for CAPA

Danielle DeLucy

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This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.

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
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Danielle DeLucy, Pharmaceuticals, Biotechnology

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.

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