Two Day Online Course: Human Factors and Usability Engineering in the Development of Drug Delivery Products Training (September 22-23, 2021) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course" conference has been added to ResearchAndMarkets.com's offering.

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

Who Should Attend:

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

Key Topics Covered:

Legal and regulatory basis for HF

• US and EU law - the place of HF
• International usability engineering (UE) standards
• Human Factors Guidance - FDA and MHRA
• FDA and HF

HF 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 design review
• Design validation - how HF 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

HF 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

HF 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

UE process

• A practical, hands-on UE workshop, using a real combination product as an example

Generic combination products - ANDAs and HF

• HF 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?

For more information about this conference visit https://www.researchandmarkets.com/r/yv6dw6