- Module 1 - Introduction to the FDA QSR and its relationship to ISO 13485
- In this module, we will explore the purpose, scope, and structure of the FDA’s current Quality System Regulation (QSR) and the FDA’s proposal to re-modeling it and align it more closely with the international consensus standard for Quality Management Systems for medical devices ISO 13485. We will also explore the purpose, scope, benefits, structure, and key terminology of ISO 13485, its process approach, and the relationship between ISO 13485 and FDA Quality System Regulation requirements.
- Module 2 - Quality Management System
- In this module, we will cover the requirements related to establishing the QMS including the establishment of the QMS processes, change control, and QMS documentation requirements including control of documentation and records.
- Module 3 - Management Responsibility
- In this module, we will explore the role of Top Management in relation to the QMS including coverage of the quality policy, quality objectives, responsibilities, authority and communication, and the management review.
- Module 4 - Resource Management
- In this module, we will explore the resources (human, infrastructure, work environment, and contamination control) that are required to implement and maintain the QMS.
- Module 5 - Product Realization, Part 1
- In this module, we will explore the requirements related to pre-production and service provision, namely: customer-related processes, design and development, and purchasing.
- Module 6 - Product Realization, Part 2
- In this module, we will explore the requirements related to production and service provision and control of monitoring and measuring equipment.
- Module 7 - Measurement, Analysis and Improvement
- In this module, we will explore the requirement related to monitoring and measurement including feedback and complaint handling. We will also cover reporting, the internal audit, and control of nonconforming products.
It explains what a Quality Management System is and how it works and further explores requirements including Management Responsibility, Resource Management, Product Realization and Measurement, Analysis, and Improvement.
Following the FDA’s recent QSR remodeling proposal to align the current requirements to ISO 13485, this course will also explore the relationship between ISO 13485 and FDA Quality System Regulation requirements.
On completion, 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
Who Should Attend?
This course would be targeted at:
- Quality Engineers
- Quality Specialists
- Internal Auditors
- Quality Managers
- Regulatory Professionals
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)
Upon registering for this course, each Learner will have 90-days of eLearning access to complete the course, including final assessment.
Recommended Prior Learning
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
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.
Click here to read the full technology requirements.
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