2-hr Virtual Seminar: Advanced Root Cause Analysis and CAPA Investigations


CAPA is the corner stone of an effective Quality System for Medical Device companies. However, it is still the number one cause of 483 and Warning Letter Observations. Without an accurate root cause analysis it is impossible to correct and prevent quality and compliance issues. Many companies struggle with inadequate root cause analysis resulting in on-going quality and compliance problems.

This webinar will help you improve your root cause analysis leading to real and lasting improvements.

CAPA is the corner stone of an effective Quality System for Medical Device companies. However, it is still the number one cause of 483 and Warning Letter Observations. Without an accurate root cause analysis it is impossible to correct and prevent quality and compliance issues. Many companies struggle with inadequate root cause analysis resulting in on-going quality and compliance problems.

Course Objectives:

• FDA expectations for CAPA, Root Cause Analysis, documentation
• Discuss lessons learned from 483s and Warning Letters
• Learn about problem solving methods
• Discover tools and techniques for Root Cause Analysis
• Good Documentation Practices
• Case studies

Why Should You Attend:

Conducting an effective root cause analysis is not easy. This webinar will give you insights and lessons learned from an industry expert with 30 years’ experience. You will learn how to get permanent resolution to your quality problems.

Course Outline:

• Build the right team
• Develop a problem statement
• Data collection
• Analysis tools and techniques
• How to verify your results
• RCA tool box
• Real lessons learned
• Dos and don’ts of RCA
• Case studies

What You Get:

•  Training Reference Materials
•  Live Q&A with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

Who Will Benefit:

• QA Management
• CAPA Coordinator
• Regulatory Affairs Management
• Executive Management
• Consultants
• Quality System Auditors
• Quality, Manufacturing, Design, or Process Engineers
• Compliance Specialists, Auditors
• Compliance Managers
• CAPA Specialists / Managers

Susanne Manz,

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. She 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.

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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LIVE : Scheduled on 24-October-2019 :01:00 PM EDT
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