Statistical Concepts of Process Validation - Webinar Recording/Transcript

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Statistical Concepts of Process Validation

Many a medical devicemaker has incurred a warning letter due to slipshod process validation. No wonder. Process validation is an exacting task, subject to strict statistical procedures and hemmed in by 21 CFR §820.75 and ISO 13485:2016.

But compliance is only half the story. Failure in process validation leads to liability and lawsuits, while excellence in product validation leads ultimately to greater profits.

It’s time to brush up your process validation procedures and the perfect coach is Dan O’Leary, FDAnews’s go-to guy on technical training for devicemakers. 

Presentation Takeaways: 

  • QSR requirements for process validation
  • The FDA’s approach as documented in warning letters
  • ISO 13485:2016 requirements for process validation
  • Linking process input and process output: The statistical model
  • Linking sampling verification to the process model
  • Role of process capability and desired values of indices
  • Designed experiments: Role in determining input parameter space
  • Challenge points: Role in Operational Qualification
  • Risk management: Process validation’s role

Process validation is a process, one calling for patience and precision, training and retraining. Grab this opportunity for 90 minutes of training (or retraining) with the best in the business.

  • Quality Managers
  • Quality Engineers
  • Production Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Design Engineers
  • Production Process Owners
  • Regulatory Affairs

Dan O’Leary, one of FDAnews’s most sought-after presenters, is President of Ombu Enterprises LLC, a company offering training and execution in Operational Excellence focusing on analytic skills and a systems approach to operations management. Mr. O’Leary has more than 30 years experience in quality, operations and program management in regulated industries including medical devices, clinical labs, aviation and defense. He 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.