Challenges Faced by End Users During the Qualification of Single-Use Systems
ABOUT
Join us to learn more about the challenges, both internal and external to the pharmaceutical industry, that users face during the qualification process of single-use systems.
Starts
14 Jan 2019, 13:30
Ends
14 Jan 2019, 15:00
Location
Online
The pharmaceutical industry has increasingly been using single-use systems (SUS) for the bioprocessing and storage of intermediate and final bulk material in addition to primary packaging. Before a SUS can be used in the manufacturing process, it needs to be qualified for use by a pre-determined process. This presentation will discuss a variety of challenges, both internal and external to the industry, that the end user faces during the qualification process. The complexity of SUS, the varying quality of vendor data, component change management, changing regulatory expectations, analytical data generation, logistical challenges during E&L study execution, analytical challenges and the potential impact of unexpected E&L study results will be discussed.
Date/Time: 14 January 2019 | 14:45 pm GMT
SPEAKERS
Dr. Ben Jeyaretnam, E&L Analytics Lead at Sanofi
Dr. Andreas Nixdorf, Team Manager/Business Development Manager, R&D at SGS