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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

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.

Location Start Date Days Cost Public Course Private
VIRTUAL DELIVERY 10/19/2020 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY 11/16/2020 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY 12/14/2020 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY 01/25/2021 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY 02/22/2021 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY 03/22/2021 5 $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. 

In-Person 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.

Online Training Schedule

This class is delivered across 5 consecutive days. For AM Sessions, Monday-Thursday sessions run 8:30 a.m.-12:00 p.m. EST (Eastern Standard Time); the Friday session runs 8:30 a.m.-2:00 p.m. EST to allow time for administering the final exam. For PM Sessions, Monday-Thursday sessions run 1:30-5:00 p.m. EST; the Friday session runs 11:30 a.m.-5:00 p.m. EST to allow time for administering the final exam.

Technical /Logistical Requirements

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

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

VIRTUAL CLASS TIMES Close

Public virtual seminars run daily from 1:30-5:00 p.m. EST (3.5 hours each day).

Auditor classes that require a final exam are extended by 2 hours on the last day to administer the final exam.

For more information download the virtual course agenda (close this window and navigate to the top of the course page) or Contact Us.

Get answers right now. Call 1.800.472.6477

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