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Public Training Course Dates & Information:

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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).

Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

Oriel STAT A MATRIX is the first provider of Exemplar Global’s QM-MDSAP Competency Unit.

Can't travel? This class is also available virtually.

Designed for experienced auditors, course participants learn how to apply MDSAP's process-based approach and align your current internal audit program to the MDSAP requirements. We also take a detailed look at country-specific requirements for the five MDSAP participant markets: Australia, Brazil, Canada, Japan, and the United States.

* Upon completion of this class class, participants are prepared to earn an exam-based certificate that can be used as independent evidence of your training and qualification to maintain MDSAP compliance. 

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  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
VIRTUAL DELIVERY (PM) 04/27/2020 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 05/11/2020 5 $2995.00 Add to Cart CONTACT US
Minneapolis, MN 06/02/2020 4 $2995.00 Add to Cart CONTACT US
San Francisco Area, CA 06/29/2020 4 $2995.00 Add to Cart CONTACT US
Orlando, FL 08/04/2020 4 $2995.00 Add to Cart CONTACT US
Edison, NJ 09/01/2020 4 $2995.00 Add to Cart CONTACT US
Chicago, IL 09/29/2020 4 $2995.00 Add to Cart CONTACT US
San Diego, CA 10/27/2020 4 $2995.00 Add to Cart CONTACT US
Boston, MA 12/01/2020 4 $2995.00 Add to Cart CONTACT US

Learning Objectives

  • Examine MDSAP as a system audit, compliance audit, product audit, and process audit.
  • Identify requirements for auditing technical documentation and sterilization processes.
  • Review MDSAP processes, tasks, outcomes, linkages, and nonconformity grading.
  • Analyze device regulations in MDSAP jurisdictions: Australia, Brazil, Canada, Japan, and the US.
  • Review the intent and guidance for ISO 13485:2016 interpretation.
  • Evaluate objective evidence using a case study approach to simulate an MDSAP internal audit.
  • Apply a risk-based approach to designing the internal audit program.
  • Evaluate strategies for aligning the internal audit program to MDSAP.

Who Should Attend

This is an advanced auditing course and participants are expected to have hands-on experience in medical device internal auditing and a working knowledge of ISO 13485:2016.

Recommended Prerequisite

Oriel STAT A MATRIX courses Lead Auditor Training for ISO 13485  or Internal Auditor Training for ISO 13485, or significant field experience conducting ISO 13485 audits. 

Number of Days: 4
CEUs: 2.8

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.

The learning objectives and topics covered during VILT are the same as those for the in-person version of the course. To accommodate the VILT format, classes are delivered at a pace well suited to virtual instruction, and the structure of class workshops and exercises has been modified to work best in the virtual environment.

Training Schedule

This training is delivered across 5 days. Each session except for the final session is 3.5 hours per day. The final class is extended by 2 hours in order to administer the final exam.

Public seminars class times are either "Virtual (AM)" or "Virtual (PM)."

  • AM classes run 8:30 a.m.-12:00 p.m. EST for the first 4 days, and from 8:30 a.m. - 2:00 p.m on the final day.
  • PM classes run 1:30-5:00 p.m. EST for the first 4 days, and from 11:30 a.m. - 5:00 p.m. on the final day.

A typical public seminar schedule for this class would run:

  • Monday 1:30 – 5:00 PM
  • Tuesday 1:30 – 5:00 PM
  • Wednesday 1:30 – 5:00 PM
  • Thursday 1:30 – 5:00 PM
  • Friday 11:30 – 5:00 PM 

Public seminars are run on the eastern time zone to allow for attendance by west coast attendees. Additional sessions may be offered in other time zones.

Technical /Logistical Requirements

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

  • A computer with reliable, high-speed Internet connection. Broadband is preferable to WiFi.
  • Latest version of browser Firefox, Chrome, Microsoft Edge or Safari.
  • A USB-connected or built-in web cam.
  • A headset with microphone (USB connection recommended).
  • If possible, two monitors; one for the virtual classroom and the other for viewing training materials.
  • A comfortable workstation and a quiet environment.
  • To close your email browsers and refrain from using your phone during the training.
  • Tablets and mobile devices may lack some essential functionalities and are not recommended.

See course dates to find / register for a virtual session of this course.

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 1.800.472.6477 or Contact Us.

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