Training Courses
Browse our comprehensive list of pharmaceutical and biotech training courses.
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.
Process Scale-up, Validation and Technology Transfer for Medical Devices
Join medical devices online course with certificate and gain practical tools for process risk assessment during scale up of medical devices.
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.
Clinical Investigations and Evaluation for Medical Devices
Understand clinical evaluation process including regulatory requirements, the principles of clinical evaluation and study design.
Drug-Device Combination Products: Notified Body Opinion Process
Drug-Device Combination Products: NBOp
Design Control and Risk Management For Combination Products
Combination Products: Quality & Regulatory Requirements