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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).


FDA 21 CFR Part 11 – Electronic Records Training for Medical Device Companies

Warning letters related to Data Integrity are on the rise. Make sure your organization's Electronic Records meet US 21 CFR Part 11 requirements.

This class is available as a virtual instructor-led training.

In this class you will obtain knowledge and practical application experience needed for ensuring compliance to US regulations regarding electronic records, electronic signatures, and data integrity in software systems used in medical device quality management systems.  

At the end of this workshop you will be able to:

  • Describe 21 CFR Part 11 requirements for electronic records and signatures.
  • Describe US regulatory expectations and guidance for data integrity.
  • Examine how to implement risk-based and critical thinking to apply the best approach to a specific system.

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) 08/17/2020 4 $1395.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 10/20/2020 4 $1395.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 11/17/2020 4 $1395.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 12/15/2020 4 $1395.00 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 2 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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