MDSAP Fundamentals e-learning
This is a self-directed, self-paced E-learning course. You can pause the training and repeat sections as many times as you wish. Cost: €299. Access is available for 30 days. Need a quote for In-house Training? email us today info@iqc.ie
Introduction
It is essential that personnel involved in the development, implementation, and auditing of MDSAP requirements understand the core fundamentals behind the MDSAP Program.
This online training is designed specifically for those who are relatively new to MDSAP and who need a full understanding of the overall program. We recommend delegates undertaking the E-Learning then attend the more advanced MDSAP workshop where specifics can be further discussed and explained by a tutor.
Who should do this course?
• Operational Staff involved in implementing and or maintaining the systems and who are open to MDSAP audits.
• Quality personnel
• Management and Supervisors
• Any responsible personnel involved in the design, development, implementation, and auditing of quality management systems
This course is only suitable to those working in the Medical Device industry who are currently or have future potential to be open to MDSAP audits.
Course Objectives:
At the end of this e-learning training you will have a better understanding of the following topics:
1. Auditing Overview – Purpose of Audits
2. MDSAP General Overview
3. MDSAP Auditing Process Overview & Audit Types:
• Certification Audit
• Surveillance Audit
• Re-Certification Audit
• Special Audits
• Unannounced Audits
• MDSAP Conducted by Regulatory Authority
• MDSAP Requirements
• Regulatory Scope
4. MDSAP Audit Grading and Audit Duration
5. MDSAP Audit Model (AM) document
6. MDSAP Auditor Companion (AC) documents
7. EU-MDR & MDSAP
8. 13485:2016 & MDSAP & MDR
9. Feedback from Key Stakeholders – MDSAP Audit Prep
10. MDSAP Accredited Auditing Organisations