Medical Device Single Audit Program (Mdsap) Training Course
Published 3/2025
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz
Language: English | Size: 972.70 MB | Duration: 1h 41m
Introduction to MDSAP
What you'll learn
Gain a deep understanding of the MDSAP framework
Purpose, benefits, and scope of MDSAP
Key participating regulatory authorities and their requirements
Understand MDSAP regulatory jurisdictions
Requirements
No prerequisites required
Description
The Introduction to the Medical Device Single Audit Program (MDSAP) training course provides a foundational understanding of the MDSAP framework, objectives, and regulatory requirements. This course is designed for professionals seeking to gain insights into how MDSAP works, which regulatory authorities participate, and how it affects medical device compliance.MDSAP allows a single regulatory audit to meet the requirements of multiple countries, including:- United States (FDA)- Canada (Health Canada)- Brazil (ANVISA)- Japan (PMDA & MHLW)- Australia (TGA)This course is ideal for:-Quality Assurance (QA) & Regulatory Affairs (RA) professionals- Medical Device Manufacturers & Compliance Teams- Internal Auditors & Consultants- Engineers & R&D Professionals- Operations & Production Managers- Anyone preparing for or involved in MDSAP auditsWhat You'll Learn- The purpose, scope, and benefits of MDSAP- The five participating regulatory authorities and their requirements- How MDSAP aligns with ISO 13485:2016- The MDSAP audit model and process- The importance of MDSAP in regulatory complianceBy taking this course, you will gain a clear understanding of MDSAP's structure, audit process, benefits, and how it improves efficiency for medical device manufacturers operating in multiple global markets. This training will help you build confidence in navigating regulatory audits effectively.No prior MDSAP or auditing experience is required, making this course accessible to beginners. It is structured to benefit both new learners and experienced professionals seeking a regulatory refresher.
Overview
Section 1: Introduction to MDSAP Training Course
Lecture 1 Introduction to MDSAP Training Course
Lecture 2 MDSAP Participating Authorities and Audit Model
Section 2: MDSAP Regulatory Jurisdictions and Framework
Lecture 3 ISO 13485 and MDSAP Regulatory Jurisdictions
Lecture 4 MDSAP Audit Sequence
Section 3: MDSAP Audits
Lecture 5 MDSAP Audits Part 1
Lecture 6 MDSAP Audits Part 2
Lecture 7 MDSAP Audits Part 3
Section 4: Conclusion
Lecture 8 Conclusion
Regulatory affairs professionals,Quality assurance and compliance managers,Medical device manufacturers,Internal auditors,Regulatory compliance
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