Online & Self-Paced FDA Quality Systems Regulation (QSR) 21 CFR 820 + ISO 13485:2016 Course


  • Course Area:

    Medical Devices

  • Course Duration:

    12 Hours

  • Format:

    Online & Self-Paced Course

  • Accreditation:

    CQI and IRCA approved training partner
  • Individual Pricing:

    695 per person

  • Team Pricing:

    Need more! Call us

Finally, an industry-leading online, blended & virtual training solution for ISO Standards, Quality Auditing & Medical Device Regulations!

Comply Guru® offers a growing portfolio of online, virtual & blended training courses on various ISO Standards, Quality Auditing & Medical Device Regulations to enable its Learners to get the knowledge and skills they need from home, work or anywhere!

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Our self-paced, highly interactive course examines the key QSR requirements and what a quality system must include to be compliant with the QSR. It explains what a Quality Management System is and how it works and further explores requirements including Management Responsibility, Resource Management, Product Realization and Measurement, Analysis and Improvement.

Following the FDA’s recent QSR remodeling proposal to align the current requirements to ISO 13485:2016, this course will also explore the relationship between ISO 13485:2016 and FDA Quality System Regulation requirements.

Learning Objectives

  1. Identify and comprehend the basis and of the U.S FDA QSR structure , its provisions and content
  2. Discern the similarities and key differences between the U.S FDA QSR and ISO 13485
  3. Practical application of Quality System Requirements as required by U.S Regulation 21 CFR Part 820 and ISO 13485 requirements
  4. An Insight into auditors approach during Quality Management System audits

Who Should Attend?

This course would be targeted at:

  • Quality Engineers
  • Quality Specialists
  • Internal Auditors
  • Quality Managers
  • Regulatory Professionals

Course Certification

This course is certified by Exemplar Global. Successful completion will entitle each Learner to receive a digital Exemplar Global recognised Certificate of Completion.

Assessment Methodology

In order to successfully complete this online course, each Learner will need to:

  • Complete the online course modules and obtain 70% or higher in the final assessment (MCQ-based)

Course Access & Support

Upon registering for this course, a Learner will be able to avail of the following:

  • Course Access for 90-days
  • Phone & Email Support
  • Module 0 - Course Introduction

    In this module, an introduction to the course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & how to successfully complete the course.

  • Module 1 - Introduction to the FDA Quality System Regulation QSR and its relationship to ISO 13485:2016

    In this module, we will explore the purpose, scope and structure of the FDA’s current Quality System Regulation and the FDA’s proposal to  re-modelling it and  aligning it more closely with the international consensus standard for Quality Management Systems for medical devices ISO 13485:2016.

    We will also explore the purpose, scope, benefits, structure and key terminology of ISO 13485:2016, its process approach and the relationship between ISO 13485:2016 and FDA Quality System Regulation requirements.

  • Module 2 - Quality Management System

    In this module we will cover the requirements related to establishing the QMS including establishment of the QMS processes, change control and QMS documentation requirements including control of documentation and records.

  • Module 3 - Management Responsibility

    In this module we will explore the role of Top Management in relation to the QMS including coverage of the quality policy, quality objectives, responsibilities, authority and communication, and the management review.

  • Module 4 - Resource Management

    In this module we will explore the resources (human, infrastructure, work environment and contamination control) that are required to implement and maintain the QMS.

  • Module 5 - Product Realization, Part 1

    In this module we will explore the requirements related to pre-production and service provision, namely: customer related processes, design and development and purchasing.

  • Module 6 - Product Realization, Part 2

    In this module we will explore the requirements related to production and service provision and control of monitoring and measuring equipment.

  • Module 7 - Measurement, Analysis and Improvement

    In this module we will explore the requirement related to monitoring and measurement including feedback and complaint handling. We will also cover reporting, the internal audit and control of nonconforming products.

E-Learning System Requirements

The below are the recommended requirements for each Learner in wishing to complete any of our online training courses or modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS)  may be impacted, restricted and may not perform well.

Recommended Operating Systems

Windows 7/10, Mac OSX Sierra, iPad IOS10

Mobile Devices

Comply Guru’s LMS is not available on a mobile app at this time. We recommend using a web browser on a mobile device in completing any online modules. However, if completing any final graded assessment, we recommend completing via a desktop browser.

Internet Speed

We recommend using an internet connection of 256Kbit/sec or faster that will ensure that you can view videos and the online content

Recommended Internet Browsers

  • Google Chrome 32 bit version 50 or later
  • Safari 10 or later
Important Note: add-ons and toolbars can affect any browsers performance. MS Internet Explorer or Edge is not recommended as its not compatible with the LMS and the course functionality will not work properly.

Recommended Settings

We recommend that the following settings are enabled:
  • Cookies
  • Pop-ups (in both Internet Browser and security software)
  • JavaScript
  • Plugins
  • Latest Version of Adobe Flash Player
  • Latest Version of Adobe Acrobat Reader
To view all resources made available within our LMS, you will probably need Microsoft Office (Word, Excel, PowerPoint) or an equivalent (i.e Open Office, Viewer) installed.

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