Course Fee: $1,500.00 USD
This 2-Day Internal Auditor Course provides detailed training in developing the skills necessary to be an effective MDSAP internal auditor.
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).
The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.
Who Should attend?
- Personnel in an organization with responsibility for conducting internal audits to MDSAP requirements
- Departmental managers and supervisory staff new to MDSAP
- Quality Managers and Quality Engineers new to MDSAP
- Personnel with responsibility for designing and implementing medical device quality management systems
- Background and History
- What is MDSAP?
- MDSAP: Specific QMS Requirements
- The similarities and differences among the Quality Management System Requirements in different regions such as Canada, Brazil, Australia and Japan and their relevant regulations
- How the above relate to ISO 13485:2016?
- Preparation for MDSAP
- Purpose of Internal Audits
- The Audit Process
- Auditor Selection and Competence Requirements
- Audit Planning
- Conducting Audit
- Writing Nonconformities
- Audit Reporting
- Post Audit Activities