Webinar on FDA PMSR Drug Device Combination Implementation Guide.

0:00 Introduction
0:28 TODAY'S AGENDA
0:57 Logistics for this Webinar
3:09 Ground Rules
4:34 Introductions: The "Combo's Team"
7:00 Transcelerate: A Not-for-Profit Entity Created to Foster Collaboration Our Shared Vision To improve the health of people cround the world by accelerating and simplying the research and development of innovative new therapies.
8:05 External Collaboration will continue to play a critical role in achieving our future state
8:47 Interpretation of Guidance & Regulations
10:49 Approach for interpretations
11:33 Evolution of Industry
12:39 Development of the Implementation Guide
16:14 Create a Cross-functional Team
21:05 Create the Q&A Material
23:48 Create the Right Training for the Right People in the Right Functions
25:32 Create the Hazard and Reportable Malfunctions Files
27:33 Create Work Flows and Decision Trees
30:27 Polling Question
30:32 Receipt of a serious and Unexpected Event
33:00 Case Processing
34:55 Reporting to FDA
36:37 Periodic Reports: Summary and Analysis of 5-Day and Malfunction Report
38:48 Business and Supplier Agreements
43:43 Poll Question

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