Addressing CAPA within a Device Quality System


  Duration: 60 Minutes  

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Susanne Manz   Product Id : 500917
  Instructor : Susanne Manz

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Overview:

This webinar will help you ensure 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.

Why should you Attend: Corrective and Preventive Action (CAPA) is the cornerstone of a strong Quality Management System. And yet, many medical device manufacturers struggle to establish and maintain and effective CAPA process. An ineffective CAPA process leads to disastrous consequences like complaints, recalls, 483s, and warning letters. Additionally, an inefficient CAPA system leads to wasted time and resources.

Areas Covered in the Session:

  • FDA and NB expectations for CAPA
  • Lessons Learned from 483s and warning letters
  • Common problems CAPA
  • 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

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


Speaker Profile
Susanne Manz ,MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne 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 medical device companies achieve world-class quality and compliance.




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