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).
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.
On completion of this course, successful Learners will have the knowledge needed to:
- Identify and comprehend the basics of the FDA QSR structure, its provisions, and content
- Discern the similarities and key differences between the FDA QSR and ISO 13485
- Practical application of Quality 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
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
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
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
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 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.
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.
Frequently Asked Questions
Reviews & Ratings
18 global ratings
I really appreciate your platform. I really liked the variety of quizz/questionnaire format, and was positively unsettled by your mulitple choice questionnaires where the answer is not always, but still sometimes 'all of the above'. :)
A great course! I appreciated the self-pacing, and examples throughout helped put some clarity on the ISO 13485 & FDA QSR.
Training is is flexible so can do in your own time. Good to have the knowledge questions these help a lot throughout the training.
Comply Guru maintain a very high standard in their courses, they are well thought out and presented in a way that keeps your attention, continuous evaluation ensures that the learner has a good understanding of the work covered and gives them a chance to review certain areas again if necessary. Overall very good training experience
I would rate this as a 5 star feedback for a course, it is most certainly the best and most professional online course i have seen to date. Interactive even though its online - well done!