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

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.

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

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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.

Customise

Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at inhouse@management-forum.co.uk or contact us below:

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Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Training options

Public course dates

We can deliver and customise this course for any number of attendees, at your location or online. But if you have fewer colleagues, this course is running publically on:

  • 8-9 Mar 2022
  • 14-15 Sep 2022
  • 7-8 Dec 2022

Book now

Previous customers include...

  • Ablynx NV
  • Alk Abello A/S
  • AOP Orphan Pharmaceuticals GmbH
  • Bespak Europe Ltd
  • Biocompatibles UK Ltd.
  • Boehringer Ingelheim Corporate Center GmbH
  • Cambridge Design Partnership
  • Chiesi Farmaceutici SpA
  • CSL Behring
  • DCA Design International
  • Eveon SA
  • Flextronics Design srl
  • GlaxoSmithKline
  • HTL-STREFA S.A.
  • Independent
  • Indivior Plc
  • Instituto Grifols S.A.
  • Instituto Grifols SA
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Medicines and Healthcare Regulatory Agency
  • Nicovations
  • Novo Nordisk
  • Orion Corporation Orion Pharma
  • Owen Mumford Ltd
  • Portal Instruments
  • Savara Pharmaceuticals
  • Silgan Dispensing Systems
  • Vetter Pharma International GmbH
  • Worrell
  • ​ F. Hoffmann-La Roche Ltd

This training provided a comprehensive view of what is expected from regulators. [Richard] paid attention to speak clearly (appreciated from not-native English speakers) and was attentive to the participants.

Emmanuelle Tourte, Head of Regulatory Compliance & Data Management, Guerbet, Sep 21

Richard was great. He made sure we were engaged at all times and was very conscientious that we were happy with what we were learning throughout and made it clear he was happy to tailor anything to fit our needs and expectations.

Georgia Rolland, Project Co-ordinator, Cambridge Design Partnership, Sep 21

Richard was very knowledgeable, engaging and approachable. He was clearly passionate about his subject, which was infectious. I was very happy with this course and would gladly recommend it to others.

Charlie Irving, Senior Design Engineer, Renishaw Neuro Solutions Ltd, Feb 21

A great webinar on human factors. Great presenter with a lot of knowledge on the subject!

Pontus Adler, Research Scientist, Camurus AB, Feb 21

Despite being on-line it has been very interactive. The presenter is an expert on the matter and explains in a very clear and concise way.

Alba Marcé, Regulatory Affairs Specialist, Grifols, S.A., Sep 20

The content, presentation and speaker have been very good. The online version of the course has also work well. The only "problem" with the online version of the course is that we do not have direct interaction with other participants. So, at some point it would help to connect everybody with camera to share opinion or experiences.

Laura Lopez Vicente, R&D Manager, Instituto Grifols S.A., Sep 20

I like the fact that (the speaker) took the time to answer questions

Jos Wesselman, Sr. Manager Development, Basic Pharma Technologies B.V., Sep 20

I am very satisfied with the course. I learnt a lot and the subject of HFE studies is much clearer to me. We were able to have very good discussions with the speaker who seemed to be very knowledgeable.

Nina Bladh, Director CMC Regulatory Affairs, Camurus AB, Oct 19

Really great overview, could be more detailed but would require more time. Richard gets an A+

Matthew Gottschalk, Director of Human Factors - Europe, Worrell, Feb 18

All good - content and instruction

Herve Pacaud, Business Development Director, Aptar France SAS, Apr 17

Very informative, clearly giving in depth and suitable info

Emily Clements, Market Research, Nemaura Pharma Ltd, Apr 17

Speaker was very responsive to specific questions, which I appreciated

Andrea Fernandes, Manager, Integrated Care Strategy, Portal Instruments, Apr 17

Very good, pace right and a good refresher

Joe Neale, Director, Technical Development, Provensis Ltd, a BTG International Group Company, Jun 16

Very good, well presented and met my expectations - adapted to non-expert

Claire Jahan, Market Intelligence, APTAR FRANCE SAS , Jun 16

The course content is very relevant for anyone who is a beginner (like myself) in HF studies, the presentation style was informal and relaxed which helped the attendees to take part and there was plenty of useful audience participation

Valerie Joynson, Senior Scientific Assessor, MHRA, Jun 16