Obiettivo del corso
Know the fundamentals of MDSAP; Understand MDSAP audit structure and core processes; Apply and align MDSAP to internal audit programme. Please find a short introduction to our e-learning "Fundamentals of Medical Device Single Audit Program (MDSAP)" in the video below:
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. 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. 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.
Principali argomenti trattati
- 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
- Quality Assurance and Regulatory Affairs professionals
- Internal auditors, Quality engineers, Manufacturing engineers within medical device industry
System requirements Supported browsers include:
- Internet Explorer
- Firefox Additional requires include:
- A high speed internet connection will provide best results.
- An email address is required to register for courses.
- Microsoft Media Player or equivalent is needed to play audio and video files.
- Flash Player is used for content and interactive learning. If necessary download and install Flash Player to ensure proper operation of course content. What is included with the course? Each course will include access to e-learning content, quizzes, and proof of completion. Additional resources may also be included and this will vary by course. Can I pause the course and log in to it anytime? Certainly. The course allows the learner to take a break and return to it within the defined access period (typically 365 days). Are there any quizzes in the middle of the course? Our e-learning courses are designed to promote interaction between learner and content and often include quizzes. Quizzes are designed to help understand where successful learning has been achieved, and where opportunities for additional review exist. Can I get a refund if I cancel my enrollment? Refunds cannot be provided once a course is activated. Please be sure to review course information prior to activation. What happens if I don’t finish the course within the access period? The standard access period is 365 days to allow sufficient time to complete your course. If you have questions, or require assistance, you may reach us at [email protected] To learn more about TÜV SÜD, please click here..
Taining material containing the slides projected during the course, in case of online courses will be provided in electronic format. Notebook for didactic use (where provided), containing a copy of the rules necessary for the course, to be returned at the end of the course. In compliance with copyright, all the rules of the online courses can be provided for consultation only by accessing a dedicated portal. For a higher quality of teaching and preparation for exams (where applicable) it is recommended that participants purchase the reference standard directly on the official UNI store http://store.uni.com/catalogo/index.php/ or request one copy within your organization.