Human factors are a critical factor for any drug, medical device, or combination product entering the market. From self-injected drug products to complex surgical devices, human factors should be considered throughout the lifecycle of a product.
On June 29 Regulatory Mark Founder Alison Sathe and Kaleidoscope Innovation Director of Insights and Human Factors Valerie Fenster presented the Redica Systems webinar, “Human Factors – Compliance and Applications.”
The webinar is now available for instant download.
![June webinar download](https://4982731c.rocketcdn.me/wp-content/uploads/2024/01/June-webinar-ad-download.png)
What You Will Learn
- Human factors strategies from simple drug products to complex surgical devices
- Primary and secondary labeling development and evaluation for usability
- Human factors activities from product development to post-market
- International strategies: expectations for human factors in regulatory submissions in international markets
Who Will Benefit
Anyone involved in the development and post-marketing of drug products, medical devices, and combination products. Compliance and regulatory affairs teams will find the information presented valuable as well.
About the Presenters
![Alison Sathe](https://4982731c.rocketcdn.me/wp-content/uploads/2024/01/Alison-Circle.png)
Alison Sathe founded Regulatory Mark and ClearMark to provide best-in-class regulatory and quality consulting and electronic quality management systems solutions for medical devices to her domestic and international partners. As a biomedical engineer, she began her career working in medical device startups and has specialized in regulatory and quality affairs for over 15 years.
![Valerie Fenster](https://4982731c.rocketcdn.me/wp-content/uploads/2024/01/Valerie-circle.png)
Prior to working at Kaleidoscope, Valerie Fenster founded and developed a Human Factors Engineering group at Amgen. She successfully guided the human factors process and regulatory filings for combination products such as Enbrel®, Repatha®, and Aimovig® SureClick® autoinjectors and prefilled syringe devices.
Get a Demo
We’ll can show you insights into any of your key suppliers, FDA investigators, inspection trends, and much more.