Online FDA QSR 21 CFR Part 820 Training | CQI & IRCA Certified

On completion of this Online FDA QSR 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

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: 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

FDA QSR 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 QSR 21 CFR Part 820 Training Certification

CQI & IRCA 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.

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

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.