ISO 13485 & FDA QSR 21 CFR 820 Training | CQI, IRCA & Exemplar Global Certified
Online ISO 13485 & FDA QSR 21 CFR Part 820 Training that is an expansion of our existing ISO 13485 Foundation eLearning to include the FDA QMSR 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 QMSR 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.
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.
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.
On completion of this Online ISO 13485 & FDA QSR 21 CFR Part 820 Training, 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
Assessment & Certification
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 & Exemplar Global certifies our Online ISO 13485 Foundation including FDA QSR 21 CFR Part 820 Requirements Training (No. 2589). Successful completion will entitle each Learner to receive a digital Certificate of Completion recognized by CQI, IRCA & Exemplar Global.
Reviews & Ratings
11 global ratings
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!