Course objective and outcome
With the increasing number and complexity of regulatory requirements, managing all quality processes relying on manual paperwork can pose significant challenges. Moreover, from a sustainability and efficiency standpoint, adopting electronic processes is preferable to a paper-based approach.  As a result, numerous companies are transitioning to Electronic Quality Management System (eQMS) to leverage associated benefits, such as streamlined workflows, efficient document management, reduced time and costs, and cloud-based document storage and archive.
 
Participants will be introduced to the concept of eQMS and the significant advantages it offers. They will learn how to define the requirements for implementing an eQMS within their organization. The course will provide participants with the knowledge needed to begin this journey.
 
By the end of the course, participants will have a comprehensive understanding of eQMS and its advantages, as well as the prerequisites, dependencies, the importance of defining requirements, and competences involved in eQMS implementation. Furthermore, the course will assist participants in considering important factors when choosing an eQMS and supplier.
 
By providing participants with fundamental background knowledge, the course empowers them to make informed decisions while selecting an eQMS, thus avoiding unnecessary expenses and lengthy implementation processes.
 
Content

• Introduction to eQMS and its benefit in the medical device industry
• Overview of eQMS and its role in quality management
• Identifying prerequisites and requirements for successful eQMS implementation
• Selection of eQMS and providers (supplier selection, audit, etc.)
• Evaluating dependencies and their impact on eQMS integration
• Defining specific requirements for eQMS implementation
• Acquiring the necessary competences for effective eQMS implementation

The course consists of informative lectures and interactive sessions, allowing participants to engage with the content and collaborate with fellow learners. This interactive approach will enhance understanding and enable participants to apply their knowledge directly to eQMS implementation in the medical device industry.
 
Who should attend:
This course is designed for companies looking to transition from a paper-based QMS to an eQMS, as well as those seeking to upgrade or implement a new system. It is also suitable for startup companies in the process of selecting a QMS system. The following roles (from Quality assurance, Manufacturing etc.) would benefit from attending:

• General Management
• Project Managers/Directors
• Subject Matter Experts

 Trainer
Naram El-Shamary, Managing Partner, ImproveMatic