Data Analysis in QSR - Techniques and Tools to Avoid Warning Letter

Why Should You Attend:

QSR requires the device manufacturer to analyze data. Data analysis requirement present in §820.100(a) is the most frequently cited subsection. The implications are that device manufacturers must understand the requirement for data analysis and the appropriate statistical techniques and should have an effective system that identifies problems, analyzes their causes, and acts to avoid problems in FDA inspections and (MDSAP) audits. The information developed, when applied through an effective preventive action system, improves the manufacturer’s processes and helps meet compliance goals.

Attend this webinar to understand the issues and act on the information. 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 beyond just trending. The presentation uses existing methods available to anybody with Excel. As a result, you don’t to purchase expensive software for data analysis.

In addition, there is a Global Harmonization Task Force guidance document that provides a framework for implementation. The presentation covers this framework and explains how it leads to an effective system.

Bonus Material:

Participants receive a Checklist to help implement their data analysis program.

Learning Objectives:

• 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
• Know some typical data analysis scenarios
• Understand data analysis techniques available in Excel

Who Will Benefit:

• Senior management
• Regulatory affairs
• Quality assurance
• Production
• R&D and engineering
• Data analysts

Daniel O Leary
President, Ombu Enterprises, LLC

Dan O'Leary is 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 Master’s Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and certified by APICS in Resource Management.

Follow us :