About the course
To improve the safety and oversight of medical device manufacturing on a global scale, the Medical Device Single Audit Program (MDSAP) is developed to allow for a single regulatory audit of a Medical Device manufacturer by a MDSAP recognised auditing organisation, to satisfy the needs of multiple regulatory jurisdictions.
Introducing Medical Device Single Audit Program (MDSAP) Awareness course.
Through this course, you will get an overview of MDSAP, including the objectives and requirements of the audit program, and the impacts of the model to your organisation. You will also learn about benefits of MDSAP such as the reduced time to gaining access to multiple markets with a single audit program that satisfies the needs of multiple regulatory authorities.
This e-learning course is especially designed for learners on the go. It provides you the convenience of self-paced learning allowing you to boost your competency and add value to your career.
Duration of the training: 105 minutes
Login access duration: 30 days
Learning mode: Self-Paced
What will you learn from the course?
In this course, you will discover the fundamentals of MDSAP and gain an understanding of MDSAP Audit structure and core processes. In addition, you will discover how to apply and align MDSAP to the internal audit programme.
Topics to be covered in this course include:
• Overview and Objectives of MDSAP
• Benefits of MDSAP
• Roles and Responsibilities
• Uses of MDSAP
• Process Structure and Audit Tasks
• Nonconformity Grading System
• Impact of Audit Model to Organization
• Documentation and Reporting
What is the course methodology?
The course employs a variety of training tools such as content-embedded assessment, simulations, and other interactive exercises to enhance instructional delivery. Easily accessible via your preferred choice of device, the course allows you to log in and learn whenever, wherever.
The cumulative duration of the programme is 105 minutes, after which you will be required to pass a quiz to receive your internationally recognised e-certificate with a unique ID.
Who should take the course?
This course is specially designed for:
• Quality Assurance and Regulatory Affairs professionals
• Internal auditors, Quality engineers, Manufacturing engineers within medical device industry
Who is the course advisor?
Designing the course content and structure are domain experts from TÜV SÜD’s Digital Academy Approval Board.
Based in various locations worldwide, these are specialised trainers who have been working with top-notch employers and industry associations to achieve business excellence with the Medical Device Single Audit Program (MDSAP). The global reach of our experts ensures that you get access to relevant learning modules and best practices in MDSAP.