6-Hour Virtual Seminar: Death by CAPA - Does your CAPA Program need a CAPA?

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 an 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.

CAPA is so important that it is always emphasized in FDA inspections. It is consistently one of the top reasons for 483 and Warning Letter observations. It is critical that your company establishes a compliant, effective process. This seminar will also provide tools and checklists to ensure your program is inspection ready.

If your CAPA process needs a CAPA, this seminar is for you. We’ll discuss best practices so you can start off on the right foot and always be prepared for an inspection.

This virtual seminar provides detailed lectures on all elements of a CAPA program and how they connect to other parts of your Quality Management System. You will learn how to create a CAPA program that results in improved product quality, reduction in compliance issues, and ultimately leads to improved business success.

Learning Objectives:

• Understand the regulatory requirements
• Elements of creating an efficient and effective program
• CAPA process, tools, and techniques
• Linkages to your Quality Management System
• Myths, Challenges, and Best Practices
• Inspection preparedness

Areas Covered in the Webinar:

This 6 hour virtual seminar will provide you with the tools to create an effective and efficient CAPA program. Topics to be covered include:

• FDA expectations for CAPA
• Lessons Learned from 483s and warning letters
• Common problems with CAPA
• Elements of a CAPA program
• 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 CAPAs
• Sources of Data
• Analysis of Data
• Failure Investigation
• Root Cause Analysis
• CAPA Project Management
• Problem Solving and Improvement techniques
• Effectiveness Checks
• Control, Monitoring, Dissemination of Information
• Connections within your Quality Management System
• Non-conforming Product
• Corrections and Removals
• Change Control
• Statistical Techniques
• Risk Management
• Bullet-proof Reports
• Inspection Readiness and Checklist
• Best Practices

Who Will Benefit:

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

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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