Introduction
Who should attend
Features
Related Courses
The Medical Device Single Audit Program (MDSAP) is a globally recognized auditing program specifically designed for medical device manufacturers. This comprehensive training course is designed to equip participants with the knowledge and skills necessary to understand the MDSAP requirements, prepare for audits, and implement effective quality management systems compliant with MDSAP standards.
Key Focus: This course empowers professionals with in-depth knowledge and practical skills to navigate MDSAP audit expectations, manage compliance across jurisdictions, and lead successful audits.
MDSAP training helps to understand the MDSAP requirements, prepare for audits, and implement effective QMS compliant with MDSAP standards.
In addition, this MDSAP training course challenges students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, and a final assessment at the end of the course.
The course can be completed at any place. So, it allows the user to stop and start at their leisure.Â
Moreover, user can access the course at own pace. Hence, it allows the user to stop and start at their leisure.Â
Snapshot of the course
- Course Code: RYD-117
- Course Title: Competency Development Training on The Medical Device Single Audit Program (MDSAP)
- Access Duration: 1 Week course. However, user can complete the course anytime within 7 days anytime. It means, if anyone want to complete within 3 or 4 days, it is possible.
- Nature of the course : Online distance learning course. Course can be accessed online across anywhere 24×7.
- Certification: Certificate will be provided at the end of the successful completion of the course.
Who should attend?
- This course is designed for professionals working in medical device manufacturing companies, including quality assurance managers, regulatory affairs specialists, compliance officers, and anyone involved in implementing or maintaining quality management systems compliant with MDSAP standards.
Objective of the MDSAP Training
- Understand the purpose and scope of the MDSAP.
- Familiarize participants with the MDSAP audit process and requirements.
- Learn how to develop and implement a quality management system compliant with MDSAP standards.
- Gain insights into regulatory requirements and expectations across participating MDSAP jurisdictions.
- Acquire practical knowledge on preparing for and undergoing MDSAP audits.
- Learn best practices for maintaining MDSAP compliance and continuous improvement.
Important Learning Features of MDSAP Training:Â
- Online 24×7 access from anywhere. Hence, one can learn at your convenience.
- Hence, the course provides timing flexibility. In other words, one can attend the lecture sessions at your own convenient time.
- Interactive E-lectures helps user to understand of the concepts effectively.
- Above all, course provides simulation for real life working. Hence, it helps user to apply the decision making skill in real life scenarios.
MDSAP Course Coverage Area
Introduction to MDSAP
- Overview of the MDSAP program
- Objectives and benefits
- Participating regulatory authorities
MDSAP Requirements
- Key components of the MDSAP
- MDSAP audit model
- Requirements of MDSAP participating countries (USA, Canada, Brazil, Australia, Japan)
Quality Management System (QMS) Essentials
- Understanding ISO 13485:2016 and its alignment with MDSAP requirements
- Documentation and record-keeping requirements
- Risk management and CAPA (Corrective and Preventive Actions)
Preparing for MDSAP Audit
- Audit planning and preparation
- Conducting internal audits
- Corrective actions and follow-up
MDSAP Audit Process
- Audit scheduling and logistics
- Audit conduct and interactions with auditors
- Post-audit activities and responses to audit findings
Maintaining MDSAP Compliance
- Continual improvement strategies
- Monitoring regulatory updates and changes
- Addressing non-conformities and implementing corrective actions
This comprehensive online MDSAP training course aims to provide participants with the necessary knowledge and skills to navigate the complexities of the MDSAP program. Hence this training ensures the compliance with regulatory requirements and fostering a culture of quality and continuous improvement within their organizations.
