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

Private TrainingGroup Discount Save up to 25%

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).

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QMS Software Validation Training for Medical Device Companies

Course participants will obtain knowledge and practical application experience needed for validating software for use in medical device quality management systems. This includes planning, execution, and reporting of process and computer system validation activities as part of the integrated requirements of a quality management system that meets FDA and ISO 13485 requirements.

At the end of this workshop, participants will be able to:

  • Describe the regulatory requirements for software in the Quality Management System and manufacturing processes
  • Describe the essential elements for a comprehensive and flexible computer system validation (CSV) program.
  • Examine how to implement risk-based and critical thinking to apply the best approach to a specific system.
  • Manage software vendors using a risk-based approach
  • Describe requirements for spreadsheet validation

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 1.800.472.6477  |  Private training available, learn more »

Location Start Date Days Cost Public Course Private
VIRTUAL DELIVERY (PM) 09/21/2020 4 $2695.00 Add to Cart CONTACT US
San Diego, CA 10/05/2020 2 $2695.00 Add to Cart CONTACT US

Virtual Session Details

Oriel STAT A MATRIX virtual instructor-led training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

Online Training Schedule

  • This training is delivered as 4 consecutive half-day sessions.
  • Daily sessions run from 1:30-5:00 p.m. Eastern Standard Time.
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

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

Bring any of our classes to your location - Oriel STAT A MATRIX Private 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 1.800.472.6477 or Contact Us.

Get answers right now. Call 1.800.472.6477

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