CAPA is Not a 4 Letter Word: Establishing an Effective and Efficient CAPA Process

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 webinar, we’ll discuss the fundamentals of a CAPA program and how you can make your CAPA program more efficient and more effective.

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.

Areas Covered in the Webinar:

This 90-minute webinar will focus on how to improve your CAPA process to optimize efficiency and effectiveness. 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 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
• 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

Susanne Manz
President and Principal Consultant, Manz Consulting Inc

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, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and 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 is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.

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