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12hrs Online Course USD $ 995.00 ★★★★★ 18 Reviews

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

Why Comply Guru?

  • CQI, IRCA & Exemplar Global Certified
  • Self-Paced, On-Demand Learning (24/7)
  • Highly Interactive, Engaging Experience
  • Industry-leading Methodology
  • Designed by Experts with Proven Expertise
ISO 13485 & FDA QSR Foundation Training

Key Course Information

What you need to know?

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

Available Formats:

eLearning

eLearning

Customized Learning

Customized Learning

Learning Objectives Module Content Who Should Attend? Entry Requirements Assessment Methodology Course Accreditation Technology Requirements

Learning Objectives

On completion of this course, successful Learners will have the knowledge needed to:

  1. Identify and comprehend the basics of the FDA QSR structure, its provisions, and content
  2. Discern the similarities and key differences between the 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 the auditor’s approach during Quality Management System audits

Module Content

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

  • Module 1 – Introduction to the FDA QSR 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

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

Assessment Methodology

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

Course Accreditation

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.

Exemplar Global

Exemplar Global also certify this course under the Recognized Training Provider scheme. Learners will receive dual accreditation where both logos will appear on their digital Certificate of Completion.

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.

Pricing

Gain an Internationally Accredited ISO 13485 & FDA QSR 21 CFR Part 820 Certification

Advance your knowledge and enjoy instant access to your course once you register.

Secure Payment

Individual
USD $ 995.00
5% Off
Team of 5
USD $ 4725.00
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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