Online & Self-Paced FDA Quality Systems Regulation (QSR) 21 CFR 820 + ISO 13485:2016 Course
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Module 0 - Course Introduction
In this module, an introduction to the course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & how to successfully complete the course.
Module 1 - Introduction to the FDA Quality System Regulation QSR and its relationship to ISO 13485:2016
In this module, we will explore the purpose, scope and structure of the FDA’s current Quality System Regulation and the FDA’s proposal to re-modelling it and aligning it more closely with the international consensus standard for Quality Management Systems for medical devices ISO 13485:2016.
We will also explore the purpose, scope, benefits, structure and key terminology of ISO 13485:2016, its process approach and the relationship between ISO 13485:2016 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 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.