We will provide a new understanding of key topics that separate the regulatory and quality process for drugs and combination products/drug delivery devices. We understand the process for drug development and certification varies greatly from the process for medical devices. We will cover the intricacies of creating and maintaining design history files (DHF), change management techniques and human factors. The success or failure of a drug can be attributed to the user’s ability to safely and successfully use the device. Our strategies will help optimize the drug and device interplay setting up.
After completing this webinar, you will be able to:
- Understand the basics of Design History Files (DHF). Understanding Medical Device Quality Management System Requirements for Combo Products.
- Understand how Change Management works (21 CFR 820.30.i). Changing a device is different and more common than changing a drug.
- Understand the impacts and responsibilities surrounding human factors. Success or failure of a product is not just about the efficacy of the drug. It’s also about the ability of the user to successfully use the device to deliver the drug.
Moderator + Associate Editor
Medical Design and Outsourcing