Pre-Conference Deep Dive Day


Deep Dive A 9.00 - 12.00 - Comprehensive Design Control for Combination Products to Enhance Patient Experience

In this interactive session, you will learn:
• Scope and responsibilities – what devices require design control? How to devise a design and development plan that also accommodates changes?
• What are design input and documentation controls?
• Requirements of design outputs, products’ Device Master Record (DMR)
• Conducting a meaningful design review and design verification with thorough trace matrix
• The importance of design validation – test methods, process, software validation
• Assessing your risk profile to ensure a safe and quality combination product
• Handling design changes, design transfer, process validation and design history file (DHF)

Deep Dive Leader:

Alan_Golden_Head Shot

Alan Golden
Design Quality Consultants, LLC

Deep Dive B 13.00 - 16.00 - How to Leverage Human Factors at Every Stage of Combination Product Design: From Voice of Customers to Summative Usability Testing

This interactive workshop will give you a step by step guide on the below, leveraging qualitative and quantitative data to design a winning injectable device:

• Introducing human factors lifecycle as a concept
• Re-defining when and where you should begin human factors studies
• How do user requirements differ from product requirements?
• How to develop a testable list of user needs
• Specific questions that will help discover the missing wow’s
• FDA’s minimum required numbers for initial (formative) testing
• The most important criterion for getting reliable and valid data from users
• Combining qualitative and quantitative feedback to get data you can trust
• Other than numbers of participants, how does summative testing differ from formative testing?
• What does the FDA expect to see in your summative report?

Deep Dive Leader:

Joely Gardner

Joely Gardner
Professor, California State Fullerton; Chief Researcher
Human Factors Research