Online FDA QSR 21 CFR 820 and ISO 13485 Foundation Training

Online FDA QSR 21 CFR Part 820 + ISO 13485 Foundation Training

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Online FDA QSR 21 CFR Part 820 Training that is an expansion of our existing ISO 13485 Foundation eLearning to include the FDA QSR requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality System Regulation (21 CFR Part 820).

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

Why Choose eLearning for FDA 21 CFR Part 820 Training?

Our 12hr eLearning course 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.

Course Format & Content Breakdown

This Online FDA 21 CFR Part 820 Training course is available via eLearning (24/7) offering you the most convenient & flexible way to learn online, anytime, anywhere.

It is important to note that the exact time it takes to complete the eLearning modules will vary based on current knowledge, experience, and learning style.

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

Learning Objectives

On completion of this Online FDA 21 CFR Part 820 Training, 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

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:

Management Systems

  • 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.

Quality Management

  • The fundamental concepts and commonly used quality management terms and definitions

Assessment & Certification

FDA 21 CFR Part 820 Training 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

FDA 21 CFR Part 820 Training Certification

Exemplar Global certifies our Online ISO 13485 Foundation including FDA QSR 21 CFR Part 820 Requirements Training. Successful completion will entitle each Learner to receive a 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 full technology requirements

Terms & Conditions

In registering for this course, each Learner and/or Customer expressly acknowledges that they have read, fully understood and agreed to be bound by all of Comply Guru’s terms & conditions, including additional licensing agreement. The terms & conditions & licensing agreement can be read here.

Course Summary

  • Subject Area
  • Medical Devices
  • Duration
  • 12 Hours
  • Pricing
  • € 495.00 per person
  • Team Pricing
  • € 1,980.00
    (Book 4, Get 5th Free)
  • Format
  • eLearning
  • Accreditation
  • Exemplar Global
  • Exemplar Global
  • Explainer Video
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