Training Courses
Browse our comprehensive list of pharmaceutical and biotech training courses.
Design Control and Risk Management For Combination Products
Combination Products: Quality & Regulatory Requirements
AI Systems in Quality & Regulatory Affairs
Discover how AI is transforming Quality and Regulatory Affairs in this 3-day online training. Learn from industry expert James Pink how to apply AI to regulatory intelligence, submissions, QMS, and auditing while meeting FDA, EU, and ISO 42001 requirements.
Drug-Device Combination Products: Quality & Regulatory Requirements
Combination Products: Quality & Regulatory Requirements
AI Systems as Medical Devices
AI-enabled medical devices are now being assessed through multiple overlapping lenses: medical device regulations (EU MDR/IVDR, FDA frameworks), emerging horizontal regulation (EU AI Act), and rapidly evolving expectations for clinical safety, lifecycle control, and transparency. This 3-day live online training focuses on what teams need to implement to build, document, and maintain AI systems that can withstand review — from defining intended purpose and classification, through design control and risk management, to QMS integration and post-market oversight. The sessions are designed for cross-functional alignment: regulatory, QA, clinical, design, and technical stakeholders leave with a shared view of terminology, responsibilities, and evidence expectations.
Human Factors for Combination Products
Apply user-centered design principles to the development of combination products. The agenda covers all stages of documentation, risk management, design control and regulatory submissions.
Drug-Device Combination Products: Notified Body Opinion Process
Drug-Device Combination Products: NBOp