Today, Susan Neadle and Stephanie Canfield are back for part two. If you haven't listened to
part one, do that first and then come back to this episode. Susan and Stephanie chatted about Susan's new book, The
Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems. And how it brings clarity of understanding for global Combination Products guidance and regulations. Today, they continue the conversation, diving into risk management plans, control safety in the United States, and the polarizing viewpoints of ICH Q9 vs. ISO 14971.
Today's episode is hosted by
Shannon Hoste, President of Agilis by Kymanox, and Assistant Professor in the Quality Education Program at Pathway for Patient Health. She's joined by
Susan Neadle, an internationally recognized Combination Products expert, and
Stephanie Canfield, a Senior Consultant in Human Factors Engineering.
The Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry.
Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management. Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit
https://www.kymanox.com/.
The Factor is edited and produced by
Earfluence.