FDA QMSR Training (incl. ISO 13485) is for anyone who wants to understand the requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality Management System Regulation (21 CFR Part 820).

Our online training is a highly interactive way to learn at a time & pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.

Why Comply Guru?

  • CQI & IRCA + Exemplar Global Certified Training (No. 2589)
  • Self-Paced, On-Demand Learning (24/7)
  • Highly Interactive, Engaging Experience
  • Industry-leading Methodology
  • Designed by Experts with Proven Expertise
Course Snapshot
Accreditation
CQI & IRCA (No. 2589), Exemplar Global
Duration
12hrs
Available Format
eLearning
Price
USD $  795.00
Learner Rating
★★★★★ 22 Reviews

Course Overview

FDA QMSR + ISO 13485 Foundation Training

Learning Objectives Covered

Identify and comprehend the basics of the FDA QMSR structure, its provisions, and content

Discern the similarities and key differences between the FDA QMSR and ISO 13485

Practical application of Quality Management System Requirements as required by U.S Regulation 21 CFR Part 820 and ISO 13485 requirements

An Insight into the auditor’s approach during Quality Management System audits

What This Course Covers

During the eLearning modules, each Learner will cover the following:

  • Module 1 – Introduction to the FDA QMSR and its relationship to ISO 13485
  • Module 2 – Quality Management System
  • Module 3 – Management Responsibility
  • Module 4 – Resource Management
  • Module 5 – Product Realization, Part 1
  • Module 6 – Product Realization, Part 2
  • Module 7 – Measurement, Analysis, and Improvement
Who Should Attend

This course would be targeted at:

  • Quality Engineers
  • Quality Specialists
  • Internal Auditors
  • Quality Managers
  • Regulatory Professionals
Course Accreditation & Certificate

CQI IRCA

CQI & IRCA certify this course (No. 2589). Upon successful completion, each Learner shall receive a digital Certificate of Completion within 1 business day.

What Are The Entry Requirements

It is recommended that each Learner should have the following prior knowledge before completing this course:

  • The Plan, Do, Check, Act (PDCA) cycle
  • The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review, and continual improvement.
  • The fundamental concepts and commonly used quality management terms and definitions
How Will You Be Assessed

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

  • Complete the eLearning modules and obtain 70% or higher in the final assessment (MCQ-based) within the 90-day license
What Are The Technology Requirements

There are recommended requirements for each Learner in wishing to complete any of our eLearning 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. Read the full technology requirements here.

Why Choose eLearning?

Learn about how our highly interactive & engaging eLearning courses are transforming training

 
Why Choose eLearning

What Our Learners Are Saying

Read verified reviews from Learners who have completed this course.

Frequently Asked Questions

Yes, we permit substitutions provided the license has not been activated and this is requested within 30-days of the purchase date. There is no fee for substitutions.
Yes, we offer discounts. The first discount will apply for an order of 5 licenses (Team of 5). If you need more licenses, complete the request quote form as the discount will be applied based on the exact number of licenses required.
This course duration provided is an estimate based on a standard formula for the time it will take an average Learner. The precise amount of time it takes to complete the course will vary depending on your prior experience & learning style.
The standard license is for 90 days (3 months). Access is available 24/7 for the full 90-days even if you complete the course, you can still go back in and view the course content, but you cannot retake the assessments.
Each Learner is provided with 3 attempts at each final assessment. We strongly encourage all Learners to review the course content again before each attempt (if unsuccessful on an attempt). If unsuccessful after a 3rd attempt, a new course license is required (fee applies).
The fastest and easiest way to pay would be to use your credit card. If you cannot do that, and you require a PO, please email our team at training@complyguru.com
There are recommended requirements for each Learner in wishing to complete any of our eLearning 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. Read the full technology requirements here.
Once you have completed the final assessments, your certificate will be available within 1 business day via your Dashboard. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.
CQI & IRCA Accredited Training Provider

CQI & IRCA Accredited Training Provider

Offering certified courses since 2019

Exemplar Global Recognized Training Provider

Exemplar Global Recognized Training Provider

Offering certified courses since 2020