ComplianceOnline

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

Instructor: Daniel O Leary
Product ID: 705830
  • 1
  • November 2018
    Thursday
  • 10:00 AM PDT | 01:00 PM EDT
    Duration: 90 Min

Live Online Training
November 01, Thursday 10:00 AM PDT | 01:00 PM EDT | Duration: 90 Min

$249.00
One Dial-in One Attendee
$629.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD/USB Drive Free!

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$429.00

Live + Training CD/USB

$529.00

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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.

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.

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Refund Policy

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.

If you have any concern about the content of the webinar and not satisfied 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 customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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