Introduction:
A global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. The Medical Device Single Audit Program allows an MDSAP recognised Auditing Organisation 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?
This training is aimed at those with a working knowledge of a QMS from all levels within the organisation with responsibility for designing, implementing, and maintaining Quality Systems including (but not limited to): Quality Assurance Quality Control Quality Managers Regulatory Affairs External Auditors Other Departmental Managers Quality Engineers Internal Auditors
Cancellations:
Places cancelled within 10 working days of commencement must be paid in full. Substitutions may be made at any time at no additional charge.
Course Objectives:
• Identify, implement and revise internal procedures and other documents in relation to MDSAP requirements • Explain all key terms related to MDSAP • Identify all key players, including participating countries, regulatory bodies, and auditing • organizations • Explain Country-specific QMS requirements under the MDSAP • Plan and prepare for an MDSAP audit • Discuss Audit Companion Document • Understand the New Non-conformance Rating System • Explain the Audit Approval / Re-certification Timeframe
Course Summary
The 1-day course on MDSAP is highly interactive with many team exercises and discussion. Some of the specific topics covered include the following.
• Introduction to MDSAP • MDSAP implications • MDSAP and other Certifications • MDSAP Audit Differences basics • Preparing for MDSAP Audits. • Pros and Cons of MDSAP • Compliance and auditing • Three Step Audit Approval System • MDSAP Application • Audit Companion Document • New Non-conformance Rating System • Audit Approval / Re-certification Timeframe
Specific Requirements for Medical Device Registration and Labelling in Brazil – Australia – Canada - Japan compared to with EU and US medical device regulations
Training aimed at ensuring those requiring with a good working knowledge a QMS and who are/will be involved in managing / maintaining / implementing / auditing the QMS in relation to MDSAP.