Death by CAPA – Does your CAPA Process need a CAPA?

         CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This webinar will help you avoid those struggles and establish an efficient and effective CAPA process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you.

        We’ll discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. We’ll discuss best practices so you can start off on the right foot and always be prepared for an inspection.

         CAPA is the foundation of an effective Quality Management System. Yet, it frequently perceived as a burdensome and bureaucratic exercise. Many companies struggle to establish and maintain a CAPA program that is efficient and effective. An ineffective CAPA System leads to disastrous consequences such as medical device reports, recalls, 483s, and warning letters. And an inefficient CAPA program results in wasted time, money, and missed opportunities. In this session, we’ll discuss the fundamentals of a CAPA program and how you can make your CAPA program more efficient and more effective.

• FDA and NB expectations for CAPA
• Lessons Learned from 483s and warning letters
• Common problems and simple solutions
• How to structure your CAPA program Sources of data
• How to use IT tools to monitor and maintain your CAPAs
• Metrics to ensure your CAPAs are timely and effective
• The CAPA process
• A toolkit for CAPA
• Root Cause Analysis
• Failure Investigation
• Stand-alone documentation
• Best Practices
• Inspection Readiness

• Overview of the Regulations
• FDA Expectations
• CAPA Process
• Metrics, monitoring, and management
• Root Cause Analysis
• Risk Management and Prioritization
• Effectiveness Checks
• Lessons Learned and Common Mistakes
• Best Practices
• Preparing for an FDA Inspection

• Quality Systems Specialists
• Document Control Specialists
• Quality and Compliance Specialists
• Internal Auditors and Managers
• Training Specialists
• CAPA Specialists
• Project Managers
• Supplier Quality Engineers and Auditors
• Quality/Compliance managers or directors for Medical Device companies
• General Managers wanting to learn how to understand Quality System requirements