Course description
The Overview of Medical Device Single Audit Programme (MDSAP) One-Day Course is designed to provide participants with a comprehensive understanding of the MDSAP framework and its implications for medical device manufacturers seeking global market access. This course explores the principles, requirements, and benefits of participating in MDSAP audits, which harmonize regulatory requirements from multiple jurisdictions into a single audit program. Participants will learn how to prepare for and navigate MDSAP audits effectively to streamline compliance and enhance market access opportunities.
Benefits:
- Gain a comprehensive understanding of MDSAP requirements and benefits for global market access.
- Enhance readiness and strategies for preparing organizations for MDSAP audits.
- Improve compliance with regulatory requirements and streamline audit processes.
- Network with industry peers and regulatory experts to exchange insights and best practices.
Upcoming start dates
Suitability - Who should attend?
Who Should Attend:
- Quality assurance managers, regulatory affairs professionals, and compliance officers in medical device companies.
- Auditors, consultants, and advisors involved in preparing organizations for MDSAP audits.
- Stakeholders seeking to enhance understanding of MDSAP requirements and implementation strategies.
Outcome / Qualification etc.
Course Objectives:
- Understand the structure and objectives of the Medical Device Single Audit Programme (MDSAP).
- Learn about participating regulatory authorities (RA) and their roles in MDSAP audits.
- Gain insights into the audit process, including planning, conduct, and reporting requirements.
- Understand the MDSAP audit model and its alignment with ISO 13485 and other regulatory standards.
- Explore the benefits of MDSAP participation for achieving global market access and reducing regulatory burden.
- Discuss case studies and practical examples of MDSAP implementation and audit preparation.
Certification:
Participants will receive a certificate of completion upon fulfilling the course requirements, demonstrating their understanding of the MDSAP framework and requirements.
Training Course Content
Morning Session:
- Introduction to the Medical Device Single Audit Programme (MDSAP): Objectives, scope, and participating jurisdictions.
- Overview of regulatory authorities (RAs) and their roles in the MDSAP audit process.
- MDSAP audit model: Structure, audit planning, and documentation requirements.
- Alignment of MDSAP with ISO 13485 and other regulatory standards.
Afternoon Session:
- Benefits of MDSAP participation: Streamlining audits, reducing duplication, and enhancing market access.
- Audit preparation and readiness: Steps to prepare for MDSAP audits effectively.
- Case studies and practical examples: Applying MDSAP principles to real-world scenarios.
- Q&A session and knowledge assessment: Reviewing key concepts and addressing participant queries.
Course delivery details
Course Format:
- Duration: One day (8 hours)
- Delivery: Instructor-led training, available in both in-person and virtual formats.
- Interactive Learning: Case studies, group discussions, and practical exercises to reinforce learning.
- Comprehensive Materials: Participants will receive course handouts, MDSAP guidelines, and a certificate of completion.
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