3-Hour Virtual Seminar on Effective CAPA within a Device Quality System

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.

This 3-hour seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. Learn how to avoid common problems and establish an efficient and effective CAPA process leading to improved quality and compliance for your company.

In this 3-hour seminar, you'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this seminar is for you.

We'll discuss the 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.

Why should you Attend:
CAPA is the cornerstone of an effective Quality Management System. Yet, it is frequently perceived as a burdensome and bureaucratic exercise. Many companies struggle to establish and maintain a CAPA program that is both 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 seminar, we’ll discuss the fundamentals of a CAPA program and how you can make your CAPA program more efficient and more effective.

Learning Objectives:

• Understand the regulatory requirements
• Creating an efficient and effective process
• Linkages to your Quality Management System
• Myths, Challenges, and Best Practices
• Inspection preparedness

• FDA and NB expectations for CAPA
• Lessons Learned from 483s and warning letters
• CAPA Process
• Common problems and effective solutions
• How to structure your CAPA process for effectiveness and efficiency
• How to use IT tools to monitor and maintain your CAPAs
• Metrics to ensure your CAPAs are timely and effective
• A toolkit for CAPA
• Best Practices

• Quality Systems Specialists
• Document Control Specialists
• Quality and Compliance Specialists
• Internal Auditors and Managers
• Training Specialists
• CAPA Specialists
• 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