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Online Training for

Quality System Regulation (QSR)

Learn why the Quality System Regulation (QSR) is important, and how it supports your business and compliance drivers. 

Medical Device
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QSR Online Training

PathWise Quality System Regulation (QSR) web based training is an hour-long interactive module which discusses a high-level understanding of why the Quality System Regulation (QSR) is important, and how it supports your business and compliance drivers.  The course provides a breakdown of the QSR requirements and includes subpart detail. It also highlights the differences between FDA and ISO standards.

Training is done through epath, the PathWise online learning management system. ePath is on-Demand e-learning for targeted knowledge-based learning. Our web based training focuses on terms, definitions, regulations and expectations.

 QSR training is also now available in SPANISH!

Attendees of the QSR training course course learn how to:

  • Explain why we follow the FDA QSR.
  • Identify general compliance expectations.
  • Identify the key elements of the QSR.
  • Explain the key differences between the FDA QSR and ISO Standards.

These are the benefits of the cGMP web based training:

    • Optimize productivity and training time.
    • Flexible mobile learning using a desktop, laptop, tablet or mobile device.
    • Fulfill new hire and annual FDA training requirements.

Quality System Regulation is taught as an e-learning course to provide an overview of The Quality System Regulations and ISO 13485. It can be taken through our ePath learning system on a desktop, phone, or tablet.

QSR training is appropriate for all employees involved in the manufacture or support of the medical device industry.

The QSR online training module is worth 0.1 CEU credits.

PathWise is accredited by the International Association for Continuing Education and Training (IACET).  PathWise complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, PathWise is accredited to issue the IACET CEU.

Learners must complete the following in order to earn CEU credit:

  • Verify your electronic signature
  • Complete the full course module on ePath
  • Complete the full instruction module
  • Complete the post course assessment on ePath with an 80% score or better (learner will be given 2 opportunities to take the assessment).

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