Скачать или смотреть REdI Annual Conference 2024: CDRH (Devices) Innovation in Medical Product Development (Day 2 of 2)

Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities. See individual presentation below.

4:10 Welcome to RedI 2024 Device Track, Part 2 – Elias Mallis and Joseph Tartal
20:38 Overview of the Final Rule and the Quality Management System Regulation – Joseph Tartal
57:44 Introduction of Tonya A. Wilbon
59:48 An Innovative Approach to Navigating the Quality Management System Regulation - Tonya A. Wilbon
1:54:03 Introduction of Indira Rao Konduri, MS
1:56:19 UDI for Patient Safety and Transformation - Indira Rao Konduri, MS
2:31:40 Introduction of Ruth Bediakoh
2:32:45 Global Market Innovation with Medical Device Export Certificates - Ruth Bediakoh
4:27:10 Welcome Back from Break
4:27:46 Introduction of Dianna Kenner-Staves, PharmD
4:29:31 Medical Device Reporting: Viewing Adverse Events as Opportunities for Transformation - Dianna Kenner-Staves, PharmD
5:05:31 Introduction of Katelyn Bittleman, PhD
5:06:51 Innovations in Medical Device Remanufacturing and Servicing - Katelyn Bittleman, PhD
6:08:27 Welcome Back from Break
6:09:23 Introduction of Sara Onyango, DHSc, MPH, MSN
6:12:30 Step into the Closing Meeting: Navigating an FDA Closeout and Beyond - Sara Onyango, DHSc, MPH, MSN
6:47:56 CDRH Track Closing Remarks – Joseph Tartal