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A customizable, cost-effective solution for groups of 5 or more. Contact us to learn more »

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Enroll three students in the same course (held on the same date and at the same location) at the regular price and receive a fourth enrollment for free. *This offer cannot be combined with any other promotional offer(s).

New! 

Performance-Based Auditing for Medical Devices
A Tool for FDA’s Case for Quality

Calling all experienced auditors!

FDA’s Case for Quality seeks to elevate the focus of the medical device industry from compliance to practices that support medical device quality and safety.

However, FDA has not provided a methodology to achieve this goal. Oriel STAT A MATRIX has. Fusing decades of auditing expertise and performance improvement consulting experience, Performance-Based Auditing for Medical Devices presents a methodology to move your audits beyond compliance.

Participants in this class learn how to analyze process performance data and document the:

  • Effectiveness of the management system in achieving business results.
  • Efficiency of the management system processes toward achieving business results with the least amount of resources.

Armed with this information, you will have the skills and knowledge to analyze data and identify opportunities to improve process performance, product quality, and customer satisfaction. This information allows you to speak the language of the boardroom: dollars and cents. As well, it is key to FDA’s Case for Quality and its focus on the use of critical-to-quality design and production practices that support higher-quality results. 

NOTE: This course uses Minitab statistical software. Students must bring personal laptops to class loaded with the latest version of Minitab. A free 30-day trial version of Minitab 17 can be found at www.minitab.com

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.888.532.6360  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
Edison, NJ 07/10/2017 5 $2995.00 Call to Register CONTACT US
Chicago, IL 08/07/2017 5 $2995.00 Add to Cart CONTACT US
Boston, MA 10/16/2017 5 $2995.00 Add to Cart CONTACT US

Objectives

  • Recognize the difference between compliance-based auditing and performance-based auditing.
  • Learn how a performance-based audit program connects process metrics to key indicators of business performance.
  • Learn how to apply:
    • Performance-based methodologies for preparing and conducting audits.
    • Statistical tools that assess process performance and product characteristics, including the use of Minitab statistical software.
    • A process performance scoring system (and connecting it with nonconformities).

Topics

  • The fundamentals of performance-based auditing:
    • More robust methodologies for preparing and conducting audits
    • Auditor competence
    • Enhanced audit criteria that consider efficiency and effectiveness
    • Applied statistics for auditing
  • Planning, conducting, and reporting a performance-based audit
  • Linkages between the process approach to auditing and key performance indicators (KPIs)
  • Measuring audit program effectiveness

Who Should Attend

Designed for experienced management system auditors who have successfully completed an auditing course and performed actual audits, as well as audit program managers and QMS management representatives.  

Number of Days: 5
CEUs: 4.4
On-Site Training Close

The dates you choose. The location you want.
The results you need!

Bring any of our classes to your location - Oriel STAT A MATRIX on-site training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.888.532.6360 or Contact Us.

Our team is here to help. Call 1.888.532.6360 or contact us online ›