2-hr Virtual Seminar: Advanced Root Cause Analysis and CAPA Investigations
Duration : 2 Hours
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 Engineerin Read more
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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
