Presented by
Management Forum
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.
★★★★★ "Richard is very knowledgeable in the topic and was able to answer all questions by providing both re... more (21)"
5-6 March 2024
+ 5-6 June 2024, 17-20 September 2024, 5-6 December 2024 »
from £1099
- 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.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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
The Human Factors and Usability Engineering in the Development of Drug Delivery Products course will cover:
Legal and Regulatory Basis for HF (FDA / MDR)
- US and EU legal framework for Human Factors
- International standards - IEC62366 and ISO14971
- Human Factors Guidance – FDA, EMA and MHRA
Integrating HF and Drug Device Development
- 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 (IND/IDE)
- FDA guidance - what does it say about HF and clinical trials
- 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
- INDs and IDEs - the role of human factors in applications
- Changing the device during clinicals - HP implications
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
- Early stage formative evaluation of 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?
- Due diligence - what types of HF technical data to include
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?
Richard Featherstone
Knowledge Specialist Ltd
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.
NEW higher discounts for multiple bookings - 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*
Please contact us for pricing if you are interested in booking 5 or more delegates
5-6 March 2024
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 14124
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 30 Jan
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
5-6 June 2024
Classroom
Rembrandt Hotel
London
09:00-17:00 UK (London)
Course code 13550
Optional £200/€290/$330 per night
- GBP 1,299 1,499
- EUR 1,869 2,149
- USD 2,137 2,449
Until 01 May
- 2 days classroom-based training
- Optional accommodation - 2 nights including breakfast, checking in the day before the course
- Meet presenters and fellow attendees in person
- Lunch and refreshments provided
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
17-20 September 2024
Live online
13:30-17:00 UK (London) (UTC+01)
14:30-18:00 Paris (UTC+02)
08:30-12:00 New York (UTC-04)
Course code 13803
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 13 Aug
- 4 sessions of live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
5-6 December 2024
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 13998
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 31 Oct
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
Reviews of IPI's Human Factors and Usability Engineering in the Development of Drug Delivery Products training course
Richard is very knowledgeable in the topic and was able to answer all questions by providing both regulatory references and examples which made understanding requirements easier.
Nov 27 2023
Geno Govender 
Senior Manager - Quality Devices, Vectura Limited
Nov 27 2023
Richard was very keen of answering any questions coming from the participants and trying to adapt the training course to the participants needs/requests.
J.Ignasi Escamilla 
Device Development Advisor, Ferrer Internacional S.A.
Mar 7 2023
Overall I really enjoyed the course - good discussions.
enrica papi
HF manager, GSK
Dec 7 2022
Everything was perfected. If i have a another chance to sign up, I definitely will do
Jiyoung Won 
Student, Dongguk University
Dec 7 2022
His lecture was so good. Thank you
Jinsoo Lee
Student, Donggukuniversity
Sep 14 2022
A+, one of the best webinars I've attended. I was hoping to learn more about Human Factors development to strengthen our R&D team. The presenter, Richard Featherstone, was excellent at going over every single detail. Was definitely accomplished. Richard was very thorough and informative for an individual who had no prior experience with Human Factors. The simplicity, organization, overall flow, and the amount of information within the webinar.
Brent Nelson 
Director, Analytical R&D/QC, Renaissance Lakewood, LLC.
Sep 27 2021
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 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
United Kingdom
- 3M
- Bespak
- Bespak Europe Ltd
- Biocompatibles UK Ltd.
- Boston Scientific
- Cambridge Design Partnership
- Chiesi
- DCA Design International
- GlaxoSmithKline
- GSK
- 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
- Pfizer R&D UK
- Presspart Manufacturing Limited
- Provensis Ltd, a BTG International Group Company
- Renishaw Neuro Solutions Ltd
- Springboard Pro Ltd
- Vectura Limited
- Worrell
France
- AdhexPharma
- APTAR FRANCE SAS
- Becton Dickinson
- Eveon SA
- Guerbet
Germany
- Boehringer Ingelheim Corporate Center GmbH
- Boehringer Ingelheim GmbH & Co KG
- Boehringer Ingelheim Pharma GmbH & Co. KG
- medac GmbH
- Vetter Pharma International GmbH
United States of America
- Portal Instruments
- RAI SERVICES COMPANY
- Renaissance Lakewood, LLC.
- Savara Pharmaceuticals
- Silgan Dispensing Systems
Denmark
- Alk Abello A/S
- Novo Nordisk
- Novo Nordisk A/S
- Zealand Pharma A/S
Spain
- Ferrer Internacional S. A.
- Ferrer Internacional S.A.
- Grifols, S.A.
- Instituto Grifols S.A.
Italy
- Chiesi Farmaceutici
- Chiesi Farmaceutici SpA
- CHIESI SPA
Korea, Republic Of
- AJOU University
- Dongguk University
- Donggukuniversity
Netherlands
- Basic Pharma Technologies B.V.
- Venn Life Sciences ED B.V.
Switzerland
- CSL Behring
- F. Hoffmann-La Roche Ltd
Belgium
- Ablynx NV
Finland
- Orion Corporation Orion Pharma
Ireland
- Emergent BioSolutions
Israel
- Flextronics Design srl
Lithuania
- AOP Orphan Pharmaceuticals GmbH
Poland
- HTL-STREFA S.A.
Sweden
- Camurus AB
Run Human Factors and Usability Engineering in the Development of Drug Delivery Products Live online/Classroom for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
