Failure Investigations - Webinar CD/Transcript

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Failure Investigations: Treating the Root Cause, Not the Symptoms

Do you have a problem that needs investigating?

How do you document the investigation so that regulators can see you’re on top of the situation?

Karl Vahey, Senior Director QA, Manufacturing Asia and Europe at Medtronic, walks you through a step-by-step guide to effective root cause analysis.

You’ll learn:

  • The importance of a failure investigation
  • The key steps in a failure investigation
  • How is industry performing
  • Investigation tools & examples
  • Good investigation practices
  • Lessons learned

Order today and learn how to conduct an effective root cause analysis.

Creating the procedures, developing the records, and ensuring compliance is a team effort involving many functions and disciplines. This includes people in the following roles:

  • Quality Managers
  • Quality Engineers
  • Quality Auditors
  • Regulatory Managers
  • Complaint Handling Specialists
  • Data Analysts
  • Adverse Event Specialists

Karl Vahey, Senior Director QA, Manufacturing Asia and Europe, Medtronic
Karl Vahey is currently the Senior Director QA, Manufacturing Asia and Europe with Medtronic. Karl has 25 years of experience in the medical device industry and has worked in Manufacturing, Quality Assurance, Regulatory Affairs and Quality Systems Compliance. His current responsibilities include overseeing Quality Operations for manufacturing facilities in Asia and Europe.