Fundamentals of Medical Device Awareness Single Audit Program (MDSAP)

Online Course

Online Course

Course Description

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 recognized auditing organization, to satisfy the needs of multiple regulatory jurisdictions.

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 program.

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.

course preview

WHO WILL BENEFIT

  • Quality Assurance and Regulatory Affairs professionals
  • Internal auditors, Quality engineers, Manufacturing engineers within medical device industry

Learning Objectives

  • Know the fundamentals of MDSAP
  • Understand MDSAP audit structure and core processes
  • Apply and align MDSAP to internal audit program

COURSE AGENDA

  • 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

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.

Once you complete the duration of the course you will be required to pass a quiz to receive your internationally recognized e-certificate with a unique ID.

 

Next Steps

Site Selector