(Part 2) Winning Formula: Combination Products Unveiled, with Susan Neadle

0 Visualizzazioni· 07/19/23
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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.
About The Factor:
To err is human. That’s where we come in. The Factor is your trusted podcast for the global medical market. We are highlighting various topics and viewpoints within our industry. Our goal is to create dialogue that promotes best practices in creating safer medical products for the end user.  It is brought to you by Agilis by Kymanox, and is produced by Earfluence.

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