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MDSAP - How To Implement MDSAP - Requirements Into Your ISO 13485 Quality Management System?
- What is the Medical Device Single Audit Program (MDSAP)
- Which companies must have MDSAP
- Which companies should have MDSAP
- Which companies should postpone MDSAP
- What are the requirements of MDSAP
- How to implement MDSAP in a smart way into a quality management system according to 13485, 21 CFR 820 (QSR) or any other regulatory framework
- How the MDSAP-Audit is working
- What is the difference between MDSAP and European Notified Body Audits
Overview of the webinar
This course will give an introduction into the Medical Device Single Audit Program (MDSAP). The introduction will give an overview of the program definition, the requirements for the quality management systems defined by the member states of this program (Australia, Brasilia, Canada, Japan, US), how a smart implementation of these requirements in the quality management system is possible and finally how the audit for five countries (Australia, Brazil, Canada, Japan, US) in one audit is working. After this webinar, you are able to explain the hot topics of MDSAP, how the program is working and what is essential for the audit and the audit preparation.
Who should attend?
- CEO’s
- Regulatory Affairs Managers
- Quality Managers
- Quality Representatives
- Regulatory Managers
- Quality Guidelines Managers
Why should you attend?
You should attend this webinar to understand, what is MDSAP and how is MDSAP working. Your implementation time should be short and need smart ideas to reach the right level to pass the MDSAP - Audit by your audit organization. After this webinar, you are able to explain the hot topics of MDSAP, how the program is working and what is essential for the audit and the audit preparation.
Faculty - Prof.Dr. Dr. h.c. Frank Stein
Prof. Dr. Dr. h.c. Frank Stein, medical & physical engineer, medical engineering experience since 25 years, food experience since 6 years with HACCP, IFS 6.1, BRC 8, FSSC22000, risk management experience since 15 years, experience with borderline products food-medical, international project and regulatory consulting experience in EMEA, APAO, LATAM, US.