Presented by
Management Forum

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.

8-9 Mar 2022 + 2 more dates

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  • Format: Live online, Classroom
  • CPD: 12 hours for your records
  • Certificate of completion

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

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The Human Factors and Usability Engineering in the Development of Drug Delivery Products course will cover:

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?

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Richard Featherstone

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.

More details

Book Human Factors and Usability Engineering in the Development of Drug Delivery Products Live online/Classroom training

8-9 Mar 2022

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 11561

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 01 Feb

In your basket 

14-15 Sep 2022

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 11694

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 10 Aug

In your basket 

7-8 Dec 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11374

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 02 Nov

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

Reviews of IPI's Human Factors and Usability Engineering in the Development of Drug Delivery Products training course


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.

Sep 27 2021

Georgia Rolland
Project Co-ordinator, Cambridge Design Partnership

Sep 27 2021

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

Feb 23 2021

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

Pontus Adler
Research Scientist, Camurus AB

Feb 23 2021

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

Sep 30 2020

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

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

Sep 30 2020

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 30 2020

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.

Oct 2 2019

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

Feb 27 2018

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

Matthew Gottschalk
Director of Human Factors - Europe, Worrell

Apr 5 2017

Very informative, clearly giving in depth and suitable info

Emily Clements
Market Research, Nemaura Pharma Ltd

Apr 5 2017

Speaker was very responsive to specific questions, which I appreciated

Andrea Fernandes
Manager, Integrated Care Strategy, Portal Instruments

Apr 5 2017

All good - content and instruction

Herve Pacaud
Business Development Director, Aptar France SAS

Jun 15 2016

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 15 2016

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

Claire Jahan
Market Intelligence, APTAR FRANCE SAS

Jun 15 2016

Very good, pace right and a good refresher

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

UK

  • 3M
  • Bespak Europe Ltd
  • Biocompatibles UK Ltd.
  • Cambridge Design Partnership
  • DCA Design International
  • GlaxoSmithKline
  • Independent
  • Indivior Plc
  • Maddison ltd
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Medicines and Healthcare Regulatory Agency
  • MHRA
  • Nemaura Pharma Ltd
  • Nicovations
  • Owen Mumford Ltd
  • Presspart Manufacturing Limited
  • Provensis Ltd, a BTG International Group Company
  • Renishaw Neuro Solutions Ltd
  • Worrell

Denmark

  • Alk Abello A/S
  • Novo Nordisk
  • Novo Nordisk A/S
  • Zealand Pharma A/S

France

  • AdhexPharma
  • APTAR FRANCE SAS
  • Eveon SA
  • Guerbet

Germany

  • Boehringer Ingelheim Corporate Center GmbH
  • Boehringer Ingelheim Pharma GmbH & Co. KG
  • medac GmbH
  • Vetter Pharma International GmbH

Spain

  • Ferrer Internacional S. A.
  • Grifols, S.A.
  • Instituto Grifols S.A.

United States of America

  • Portal Instruments
  • Savara Pharmaceuticals
  • Silgan Dispensing Systems

Switzerland

  • CSL Behring
  • ​ F. Hoffmann-La Roche Ltd

Belgium

  • Ablynx NV

Finland

  • Orion Corporation Orion Pharma

Israel

  • Flextronics Design srl

Italy

  • Chiesi Farmaceutici SpA

Lithuania

  • AOP Orphan Pharmaceuticals GmbH

Netherlands

  • Basic Pharma Technologies B.V.

Poland

  • HTL-STREFA S.A.

Sweden

  • Camurus AB

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy