Advanced Root Cause Analysis and CAPA Investigations

Duration: 120 Minutes
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.
Advanced Root Cause Analysis
Instructor: Susanne Manz
Product ID: 500993

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.

Areas Covered
  • 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
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.

Objectives of the Presentation
  • 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
Who can Benefit
  • Quality, Manufacturing, Design, or Process Engineers
  • Compliance Specialists, Auditors
  • Compliance Managers
  • CAPA Specialists / Managers
  • Regulatory Affairs Managers
$375
Recorded Session for one participant
Get life time access with download option!
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  $500.00 Training CD
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Minimum 10 attendees
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Live Session - How it works
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  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Susanne Manz 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.
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