- Home
- Human Factors and Usability Engineering in the Development of Drug Delivery Products
Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course
Applying HF and usability to comply with the MDR.
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.
Details
Course overview
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.
Why you should attend
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
Programme
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?
Presenter
Richard Featherstone (More...)
Richard Featherstone was one of the early pioneers of applying human factors research methods to combination products, having set up Medical Device Usability in 2008. Richard has been designing and conducting human factors studies for over 15 years, and his experience includes a wide range of drug delivery technologies including inhalers, auto-injectors, nasal sprays and associated devices such as tele-health systems. Following his most recent role as Research Director in Human Factors for Emergo by UL, Richard is now providing freelance consultancy and training services. Richard has advised some of the world’s largest pharmaceutical and medical device companies as well as small start-ups. Over 15 years of human factors work has meant that Richard has built a considerable body of knowledge of the regulatory requirements for usability testing, in particular in a European context.
Book now
Book now
NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate
- 40% off the 3rd delegate
- 50% off the 4th delegate
|
14-15 Sep 2022 Live webinar 09:30-17:00 UK (London) |
|||
|
14-15 Sep 2022 Live webinar 09:30-17:00 UK (London) |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 10 Aug* |
Enrol now
to attend Live webinar |
|
|
7-8 Dec 2022 Face-to-face, Rembrandt Hotel London 09:00-17:00 UK (London) |
|||
|
7-8 Dec 2022 Face-to-face Rembrandt Hotel London 09:00-17:00 UK (London) |
GBP 1,499 1,299 EUR 2,099 1,819 USD 2,338 2,026 Until 2 Nov* |
Enrol now
to attend Face-to-face Rembrandt Hotel London |
|
Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.