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


Instructor: Daniel O Leary
Product ID: 705830

  • Duration: 90 Min
This webinar will help understand data analysis requirements for QSR, the techniques to identify problems, analyze cause and action plan preparation to avoid FDA inspection and MDSAP audits. It will help you understand how to pick right data analysis techniques from ISO/TR 10017:2003 and how to analyze data in excel.
Purchase option for this webinar is currently unavailable. Please contact our Customer Care for more info. Webinar All Access Pass Subscription


Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

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
Instructor Profile:
Daniel O Leary

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 :



Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube


Copyright © 2023 MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method