Death By CAPA - Does Your CAPA Program Need a CAPA? - Webinar

  • ID: 4428088
  • Webinar
  • 90 Minutes
  • NetZealous
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This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) 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 will 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.

Why You Should Attend: CAPA is the corner stone 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 webinar, we’ll discuss the fundamentals of a CAPA program and how you can make your CAPA program more efficient and more effective.

Areas Covered in the Session:
FDA and NB expectations for CAPA
Lessons Learned from 483s and warning letters
Common problems and simple solutions
How to structure your CAPA process
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

Learning Objectives:
Overview of the Regulations
FDA Expectations
Lessons Learned and Common Mistakes
Best Practices
Preparing for an FDA Inspection
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  • Susanne Manz Susanne Manz,


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  • Product Design Engineers
  • Quality Management and Engineers
  • Regulatory Affairs
  • Project Managers
  • Staff evaluating risk, safety, and effectiveness
  • R&D Staff - engineering and lab personnel
  • Process Engineers
  • Packaging Engineers
  • Materials Engineers
  • Manufacturing Engineers
  • Liability - Lawyers, Paralegals
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