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Quality System Regulation Instructor Led Training


This two day course Quality System Regulation (QSR) training focuses on 21 CFR Part 820 Quality System Regulation issued by the Food & Drug Administration (FDA) with a comparison to the International Organization for Standards (ISO). We also cover 21 CFR Part 11 on Electronic Records. This course is an in-depth discussion of why the Quality System Regulation is important and supports your business and compliance drivers. The course provides brief history and of the FDA. It contains a breakdown of the QSR requirements, non-compliance consequences and includes subpart detail.  It also highlights the differences between FDA and ISO standards. Activities included in the course focus learners on the Quality Systems depicted in the regulations.

Attendees of this 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.
  • Discuss Part 11 compliance.
Attending the Quality System Regulation training course has these benefits:

  • Drives compliance understanding.
  • Hands-on activities to apply to your quality system.
  • Fulfill new hire and annual FDA training requirements
QSR training is appropriate for all employees involved in the manufacture or support of the medical device industry.

Two Days of Instructor Led Training.

Quality System Regulation 2 day training is worth 1.5 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.

TrainingThe most cost effective training option is to have PathWise come to your location. We have trainers across the globe, and trained in 14 different countries in 2015 alone, covering almost every continent!

To schedule a course at your site fill out the form below and a PathWise representative will get back with you shortly!

TrainingWe understand that training is essential to achieve and maintain a compliant, effective and efficient quality system, which is why 90% of our courses are taught on-site at our client’s locations.  For individuals and organizations in need of training but unable to make an on-site training commitment, we offer many of our courses as events at a variety of locations across the globe.

View the PathWise Events page to find out about our options for a public workshop.