Best Practices in CAPA Management and Root Cause Analysis

Product Id : FDA142
Instructor : Danielle DeLucy
Nov 20, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

Download Conference Material

Download Here (Password Needed)


According to the U.S. Food and Drug Administration (FDA), the purpose of Corrective and Preventive Action (CAPA) is to “collect and analyze information to identify actual and potential product and quality problems, and take appropriate and effective corrective or preventive action.” As per a report by the FDA Group, procedures for CAPA remained the most-often cited compliance issue for medical device companies in 2017 as well. The lack of or inadequate procedures established for CAPA was cited 400 times in Inspectional Observations issued to the medical device industry in FY2017.

In order to solve this growing problem, organizations must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can also coach others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which allows investigators to master the process quickly and easily.

Join this webinar by quality management expert, Danielle DeLucy to get practical insights on corrective and preventive action (CAPA) best practices, including system maintenance, root cause analysis, documentation, and developing a robust CAPA plan. Learn how to outline the requirements of the CAPA process and procedure including building a CAPA file. Also, get recommendations on how to develop CAPAs pertaining to long-term projects and ensure they stay on track.

Session Highlights:

  • What to do when problems occur?
  • Corrective and Preventive Action (CAPA)
    • Definition
    • When it is required?
    • Developing essential parts of a robust CAPA plan
  • Root Cause Analysis:
    • Different methods
    • Benefits of each method
    • Choosing the most appropriate method
  • Establishing a CAPA plan
    • Project summary development
    • Individual responsibilities
    • Establishing timelines
    • Creating meaningful effectiveness checks
  • Management and oversight of the CAPA System
    • Proper documentation
    • Checking progress
    • Close out

Who Will Benefit:

  • Quality Control Personnel & Management
  • Manufacturing Personnel & Management
  • Regulatory Affairs Personnel & Management
  • Senior Management
  • Quality Assurance Personnel & Management
  • Supplier Quality Personnel & Management
Speaker Profile:

Danielle DeLucy,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.

Available Options