Process for Ensuring Clinical Trial Product Quality

Time

Tue, Jun 16 9:00AM
T 34

Title

Process for Ensuring Clinical Trial Product Quality

Abstract Summary

ORAL PRESENTATION SCHEDULED: Tuesday, June 16 in Session #1B at 1:20 - 1:25 pm Location: Exhibit Hall Poster Area (Hall A Entrance)

After the implementation of a new evaluation process for temperature excursions, we assessed 3 years of retrospective data of the temperature storage conditions of clinical trial products and the evaluation of temperature excursions compiled from current data, using Excel to perform the analysis.

Poster Presenter

Janie B. Russell
RAC,
Regulatory Affairs Specialist,
National Institutes of Health (NIH)
United States