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Management Forum

An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals Training Course

An Essential Overview

This course will cover the key regulations used globally in human factors and usability engineering, the specific standards and guidances that detail processes, methods, and the tools commonly used in medical device development that focus on the user, as well as the interaction with risk management and future business success.

24 April 2024
+ 10 July 2024, 23 October 2024 »

from £549

Need help?  Enrol or reserve

  • Format: Live online, Classroom

Overview

This intensive one-day course will introduce those who are new to medical device design and development to the critical elements of the human factors and usability engineering process. The programme shall cover the key regulations used globally in human factors and usability engineering, the specific standards and guidances that detail processes, methods and the tools commonly used in medical device development that focus on the user, as well as the interaction with risk management and future business success.

The key regulations of the Medical Device Regulation and In-vitro Diagnostic Regulation, the Code of Federal Regulations from the USA (CFR 820.30 and Titles 50 and 56) and the UK MHRA Guidance for Human Factors and Usability Engineering shall be described, along with the specific processes and tools used in IEC 62366-1 and other ISO standards specific to special medical devices. A focus on ethics, consent and user safety shall be described, along with how ISO 14971:2019 is used alongside any human factors process.

The key areas of user research and design inputs shall be described along with verification and validation activities – formative and summative human factors studies and tests so that their purpose, methodology, process and outcomes are understood. Post-market surveillance human factors shall also be detailed since this area is becoming increasingly important to include. Finally, a basic understanding of ergonomics, anthropometry, user experience and biomechanics shall be detailed before an end of the day discussion on the wider use of human factors and usability engineering shall be discussed.

Attending this event will provide delegates with a comprehensive appraisal of key aspects of human factors in medical device design and an opportunity to discuss the complexities involved with an experienced industry expert.

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

Benefits of Attending

  • Gain a comprehensive overview of the human factors engineering process
  • Comply with global regulatory requirements and standards in human factors
  • Learn about design controls and their interaction with human factors
  • Review tools that are commonly used to determine human factors data
  • Access key information on documentation management and systems
  • Understand how risk should be managed from the perspective of the user
  • Determine the benefits of human factors and usability studies 

Who Should Attend

This course will be beneficial for all those new to the area of human factors, or those who require an update or refresher  working in the following departments/roles:

  • Human Factors and Usability Engineering
  • Project Management
  • Device Development 
  • Technical Authors and Medical Writers
  • Regulatory Affairs 
  • Quality Engineers and Managers
  • Production Engineers and Managers

 

Enrol or reserve

The An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals course will cover:

Part 1: Introduction to Human Factors and Usability Engineering

  •          Defining human factors and usability
  •          Understanding what they cover
  •          Use errors, difficulties, close calls, frustrations
  •          Root causes

Part 2: The Common Porcesses in Human Factors Engineering

  •          Design controls and development methods
  •          IEC 62366-1
  •          MHRA Human Factors Guidance
  •          FDA Guidance for medical devices
  •          FDA Guidances for pharmaceutical products
  •          FDA Guidances for related aspects
  •          Related ISO standards for specific medical devices
  •          Post Market Surveillance and Clinical Feedback

Part 3: Risk Management

  •          ISO 14971 Risk Management for users
  •          Hazard-related Use Scenarios and Task Analysis
  •          Human Factors Risk Assessment
  •          Use-related Risk Assessment
  •          Formative Usability Studies
  •          Summative Human Factors Tests

Part 4: Biomechanics, Ergonomics, Anthropometry and User Experience

  •          What are biomechanics?
  •          What is ergonomics?
  •          What is anthropometry and why it is important?
  •          User Experience for medical devices
  •          Discussion on human factors engineering and its value.

 

Enrol or reserve

Greg Thay
Thay Medical

Greg Thay is owner and founder of THAY Medical, a Human Factors and Usability Engineering consultancy based in the UK and in Europe. He has worked in Human Factors since 2008 and has practised this specialism on many medical devices of all types. He has interviewed and evaluated thousands of people of all healthcare disciplines all over the world and completed many medical device developments from the human factors perspective.

Prior to human factors, Greg gained experience in orthopaedic device development, infusion therapy device development, wound care and superconductivity product development for large and small manufacturers. Since branching out into consultancy in 2010, he has grown his knowledge of design controls and human factors to ensure that he can train his staff to be competent in this field of human factors and usability engineering.

 

More details

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

24 April 2024

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 14249

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 20 Mar

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Not ready to book yet?

for 7 days, no obligation

10 July 2024

Classroom
Rembrandt Hotel
London

09:00-17:00 UK (London)
Course code 14250
Optional £280 per night

  • GBP 649 749
  • EUR 939 1,079
  • USD 1,053 1,209

Until 05 Jun

  • 1 day classroom-based training
  • Optional accommodation - 1 night 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

View basket 

 
Not ready to book yet?

for 7 days, no obligation

23 October 2024

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 14251

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 18 Sep

View basket 

 
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.

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, 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

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy