
Training: Internal & Supplier Audit
Speaker: Cédric Razaname
Duration: 2 x 3 hours
Date: November 25th and 26th 2025, Online
2 × 8:30 AM – 11:30 PM US Eastern Daylight Time (EDT)
2 × 2:30 PM – 5:30 PM Central European Time (CET)
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Training Objectives
- Learn basic methods on how to organize and conduct efficient internal and supplier audits
- Integrate an internal audit program into the Quality Management System
- Understand the importance of internal and supplier audits for the maintenance of effectiveness of a Quality Management System
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Training Content
- Definition of the audit scope
- Communication before the audit
- Documents review and questionnaire preparation
- Internal and Supplier Audit methods
- Audit conduct and ethics
- Psychology of the auditees
- Classification of findings
- Communication after the audit
- Make effective use of audit results
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Training Format
- Presentations with interactive discussions
- Group and individual exercises
- End of training assessment
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Target Audience
This course is designed for professionals involved in the design, manufacture, distribution, or regulatory oversight of medical devices and in vitro diagnostic (IVD) devices, particularly regulatory affairs and quality assurance professionals, as well as internal and supplier auditors responsible for ensuring compliance with MDR/IVDR and ISO 13485 requirements.
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Price
EUR 625, including course material and certificate