Best Practices in CAPA Management and Root Cause Analysis
Instructor : Danielle DeLucy
Nov 20, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes
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.
- What to do when problems occur?
- Corrective and Preventive Action (CAPA)
- 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