Medical Device Process Validation - Webinar CD/Transcript

$287.00
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Medical Device Process Validation

Process valiation can be a daunting propect.  What should  you do? When should you do it? What records should you keep?

With no clear guidance from the FDA, finding the answers can be difficult.

Join industry expert Dan O’Leary, President of Ombu Enterprises, LLC,  as he discusses the fundamental requirements of medical device process validation and uses warning letters to illustrate best practices.

After attending this 90-minute training session you will:

  • Understand the three phases of process validation in QSR
  • Understand the role of IQ, OQ, and PQ in the first phase
  • Learn the issues of parameter control, data collection, and data analysis applied to production runs
  • Review the QSIT approach and how FDA Investigators apply it
  • Analyze warning letters and apply lessons learned
  • Realize the differences introduced in ISO 13485:2016

Order today and discover how to set up a compliant process validation system.

  • Design Engineers, especially engineers in design transfer
  • Manufacturing Engineers, especially engineers in design transfer
  • Quality Engineers
  • Quality Auditors
  • Regulatory Affairs
  • Quality Systems Personnel
  • R&D and Engineering Staff
  • Risk Managers
  • Production Supervisors

Dan O’Leary is the President of Ombu Enterprises, LLC., a company offering training and execution in Operational Excellence, focused on analytic skills; and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including: aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.