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

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Course Description:

         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.

Why should you Attend?

         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.

Areas Covered:

Using lecture and discussion, this 90 Min session will focus on using CAPA to improve your product quality and compliance. Topics to be covered include:
  • 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

Learning Objectives
  • 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

Who will benefit?

  • 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

Registration Options


Avail 12 months unlimited access for a single user.


Material shipped within 15 days post webinar completion & get life time access for unlimited participants.



Tags


Death by CAPA, CAPA, Corrective and preventive action, CAPA Program, CAPA System, CAPA process, 483s and warning letters

Speaker Details

Susanne Manz

Susanne Manz

Medical Device Consultant

Susanne Manz, MBA, MBB, RAC, CQA has a BS in Biomedical Engineering and an MBA from the University of NM.  She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson.  Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality.  Susanne has now established a consulting business with a mission to provide services to help

Refund Policy



Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplyArena will issue a letter of credit to be used towards any of ComplyArena's future events. The letter of credit will be valid for 12 months.

ComplyArena will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: admin@complyarena.com or call +1-888-222-5917 (Toll Free).