Practical, Risk-Based Compliance & Validation
The use of artificial intelligence (AI) in quality management systems is growing rapidly and regulatory requirements are increasing at the same time. This practical seminar will show you how to implement AI applications in your QMS.
You will learn how to integrate the requirements of the EU AI Act into existing QMS processes and how to implement software validation in accordance with ISO 13485 using Computer Software Assurance (CSA) and ISPE GAMP 5. The focus is on concrete use cases and methods that can be directly applied to your daily work.
- Content
- Fundamentals of AI Regulation in Quality Management
- Classification of AI Applications According to the EU AI Act
- Risk Categories (Prohibited, High, Limited, Minimal)
- Identification of High-Risk Applications (Art. 6 & Annex III)
- Requirements for Providers and Operators of AI Systems
- Risk Management (Art. 9)
- Data governance (Art. 10)
- Technical documentation & evidence management (Art. 11–12)
- Human oversight (Art. 14)
- Accuracy, robustness & cybersecurity (Art. 15)
- Validation of AI-supported QMS software
- Requirements according to EN ISO 13485
- Implementation with CSA & GAMP 5
- Audit-ready documentation and evidence management
- AI-specific test strategies
- Bias and fairness tests
- Robustness and stress tests
- Drift control & retraining processes
- Integration of changes to AI software into the change control process
- Your Benefits
- You will understand the requirements of the EU AI Act and how to implement them in your QMS.
- You will learn how to classify and assess AI applications using a risk-based approach.
- You will be able to plan validation strategies for AI software efficiently and in compliance with standards.
- You will receive proven approaches for audit-ready documentation.
- You will know how to establish AI governance, monitoring, and human oversight in a sustainable manner.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Quality and Compliance Managers (QA/RA/QMS)
- Regulatory Affairs & Legal
- AI/ML and Product Teams
- IT, CSV, and CSA Specialists
- Managers responsible for eQMS, LIMS, MES, CAPA, and other QMS tools
- Specialists and executives from regulated industries
