Data Analysis in QSR

Duration: 90 Minutes
Data analysis is one of the most powerful improvement tools because it can lead to cost reductions and preventive action. To use these techniques you need to know both the regulatory requirements and the analysis framework. This presentation provides that essential information.
Data analysis
Instructor: Daniel O'Leary
Product ID: 507590
Objectives of the Presentation
  • Learn the difference between corrective action and preventive action - a pervasive problem
  • Understand the requirements from QSR and the expectations FDA set
  • How to pick the appropriate data analysis techniques from ISO/TR 10017:2003
  • Use the GHTF guidance document to design and implement your improvement program
  • Review FDA Warning Letters that illustrate the issues device manufacturers face
Why Should you Attend
Corrective and Preventive action is the most frequently cited section in device Warning Letters and data analysis is the most frequently cited subsection. This suggests that device manufacturers need to understand FDA’s expectations and meet them with a robust approach to data analysis. However, data analysis is more than a regulatory requirement. It is an effective method for a device manufacturer to identify problems, analyze their causes, and take action. These activities can reduce cost and increase customer satisfaction. For example, a Warning Letter points out that 17% of complaints were returns for shipping the wrong product. It concludes, "This [problem] was not identified, no investigation was performed, and no corrective action was taken."

With the appropriate framework and analysis tools, the company could have found the problem, eliminated the cost and prevented the customer dissatisfaction. Instead, an FDA Investigator uncovered the issue; now the company must take additional action (and allocate resources) to address the Warning Letter.

This presentation helps you understand the issues and take action. For example, some companies believe there is a requirement to ‘trend’ the data. However, FDA-CDRH says that is only one tool among the many statistical analysis techniques. You will learn about a recommended set of techniques and why trending is only among many viable methods.

The Global Harmonization Task Force has a guidance document that provides a framework for implementation. The webinar covers this framework and explains how you could use it to implement an effective system.

Who will Benefit
  • Senior management
  • Regulatory affairs
  • Quality assurance
  • Production
  • R&D and engineering
  • Data analysts
Bonus Material
Participants receive a checklist to help implement a data analysis program.
$375
Recorded Session for one participant
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Instructor Profile:
Dan 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.
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