Human Factors and Usability Engineering in the Development of Drug Delivery Products

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device to comply with the MDR. The format for the day will be interactive with the presenter sharing his experiences as a specialist with extensive knowledge and understanding of the requirements of the MDR, IEC 62366 and FDA Human Factors Guidance. There will be questions posed for discussion and delegates will work through some of the key aspects of performing a successful human factors study.

By attending this seminar you will:

• Understand the requirements of IEC 62366 and FDA Human Factors Guidance
• Know how to provide the regulators with specific usability data for your device
• Understand human factors and the design process
• Learn how to validate combination products
• Consider human factors and risk
• Discuss generic combination products – ANDAs and HF
• Find out what HF data FDA require for biosimilars