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.
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 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
This event will be beneficial to those working in the following areas:
Engineering and device development
Packaging
Regulatory affairs
Quality systems
Quality assurance
Risk management
Marketing
Usability and human factors engineering
Agenda
Programme Day One
Legal and regulatory basis for human factors
US and EU law - the place of human factors
International usability engineering (UE) standards
Human Factors Guidance - FDA and MHRA
FDA and human factors
Human factors and the design process
Design inputs - how HF can guide your combination product design
Design verification - examples of formative work for combination products
Design review - how to use the outputs from formative work to feed into the design review
Design validation - how human factors fits in the design validation work
Validation testing
A detailed look at validating combination products
Objectives, methods, analysis, and reporting
Common problems with validation
and how to avoid them
Latest FDA views on validation data for combination products
Human factors and risk
Use-related risk analysis (URRA)
what it is, and how it differs from FMEAs
Constructing a URRA - a practical exercise for a combination product
Risk control measures - how to use them, document them and provide evidence that they are effective
Residual risk - how to do a residual risk analysis
Programme Day Two
Human factors and the clinical trials programme
How and where HF activities work in relation to clinical trials
Differences between HF and clinical studies
How to gather usability data from your clinical programme
Usability engineering process
A practical, hands-on UE workshop, using a real combination product as an example
Generic combination products - ANDAs and HF
Human factors requirements for ANDA submissions
Critical design attributes
The role of HF in determining substitutability
Threshold analyses - latest FDA requirements
Comparative HF studies - what they are and how to run them
Ethics and IRB
When is IRB/ethics approval necessary for HF studies?
Human subject protection during HF studies - risks and mitigations
Platform devices
Sampling plans - who should you recruit if you don't know what the drug will be?
What HF data should you develop for your platform device?
Sharps prevention - simulated clinical use testing
How to satisfy the FDA guidance on simulated use of sharps prevention features
Biosimilars
What HF data does the FDA want for biosimilars?
How do FDA review the human factors data for biosimilars?
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