MDSAP Training: Lead Auditor Training Based on ISO 13485:2016 & International MDSAP Audit Model (5-Day)
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Considering the ISO 13485:2016 management system requirements and various regulatory authorities compliance requirements around the world and the global supply chains involved, a comprehensive program like our MDSAP Lead Auditor Training’ is incredibly valuable. The course provides extensive practical training and hand-on exercises, which will help prepare medical device auditors to identify critical nonconformities and meet international regulatory requirements. This training is taught in conjunction with Omnex, who is an Exemplar Global Certified provider.
Upon completion the participants will be capable to audit ISO 13485:2016 and jurisdiction requirements in the countries participating in the MDSAP program.
Participants of the training will learn from highly experienced instructors with decades of experience in medical device quality management systems.
Within the 5-Day MDSAP Audit Model, you'll learn to:
- Prepare and conduct a solo internal audit
- Understand the MDSAP audit model.
- Understand and interpret the ISO 13485 and MDSAP requirements.
- Apply the proper interpretation of the standard in actual audit situations.
- Understand process auditing tools
- Conduct audits that result in real improvements to the quality system
- Plan and execute the entire audit process
The course is designed for:
- medical device professionals with responsibility for conducting or implementing internal audits,
- supplier audits or corporate audits
- Quality directors
- regulatory managers
- professionals responsible for managing internal, corporate, supply chain
- certification responsibilities may also benefit from this unique program
Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating jurisdictions and organizations expanding their market reach to jurisdictions participating in MDSAP will also benefit from this course.
Day One
- Introduction and Welcome
- MDSAP background and Acceptability
- Written Exercise 1: Risk Assessment
- Chapter 1: Management Processes
- Chapter 2. Device Marketing Processes
- Overview of ISO 13485:2016 Requirements
- Written Exercise 2: Audit Scenarios Management Process and DMAFR
- Chapter 3: Measurement, Analysis and
Improvement (MAI) processes - Chapter 4: Adverse Event and Advisory Notices Requirements (AEANR) Processes
- Written Exercises 3: Audit Scenarios Measurement Analysis and Improvement and AEANR
Day Two
- Chapter 5: Design & Development Processes
- Written Exercise 4: Audit Scenarios – Design
& Development - Chapter 6: Production and Service Controls
- Chapter 7: Purchasing Process
- Written Exercise 5: Production and Service
Control and Purchasing - Understanding MDSAP Audit Model Final Exam
Day Three
- Chapter 8: Planning for the MDSAP Audit
- Breakout Exercise 1: Calculating Audit
Duration - Breakout Exercise 2: Audit Objectives and
Scope - Breakout Exercise 3: Preparing an Audit
Plan - Breakout Exercise 4: Documentation
Review
Day Four
- Chapter 8: Planning for the MDSAP Audit (cont’d)
- Chapter 9: Conduct an Audit Using the MDSAP Approach
- Breakout Exercise 5: Raising and Grading
Nonconformities - MDSAP Auditing Final Exam