Module 18 2021

09/02/2021

Human Factors for Drug Device Combination Products

Presenter: Greg Thay

The Organisation for Professionals in Regulatory Affairs The Organisation for

Human Factors for Drug Device Combination Products

Professionals i Regulatory Affairs

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Today’s potential learning outcomes

Question 1 – What is Usability? What is Human Factors? Question 2 - Why is Usability and Human Factors important?

Question 3 – What are the current Usability and Human Factors regulations? Question 4 – What is the Human Factors and Usability Engineering process? Question 5 – When should Human Factors and Usability Engineering be applied? Question 6 – Evaluating drug delivery devices in Human Factors and Usability Tests? Question 7 – What are the benefits of Human Factors and Usability Engineering?

The Organisation for Professionals in Regulatory Affairs

Assessing Usability and Performance during development

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