Error loading player: No playable sources found

Workshop II: Microbial In-Use Studies and Closed System Transfer Devices

Date
January 22, 2024
This product is not available for individual purchase, but it is available as part of the following products:

Session Speakers:


In-Use Studies Microbial Challenge Studies: Cross-Industry Efforts to Harmonize Strategies in Collaboration with Health Authorities

J. Paul Kirwan, Amgen Inc. 


Pharmaceutical Industry Perspective on Closed System Transfer Devices (CSTDs): Balancing Overfill, Evaluating, Communicating

Christian Lehermayr, Novartis Pharma AG


Additional Panelists:


Virginia Carroll, CDER, FDA


Nicholas Clark, Amgen Inc.


John Metcalfe, CDER, FDA


Related Products

Thumbnail for Workshop II: Process
Workshop II: Process
INCORPORATION OF PLATFORM BASED APPROACHES AND PRIOR KNOWLEDGE LEVERAGING INTO THE RECENTLY REVISED ICH Q5A (R2) GUIDELINE
Thumbnail for CASSS Welcome and CMC Strategy Forum 2024 Introductory Comments
CASSS Welcome and CMC Strategy Forum 2024 Introductory Comments
Health care providers and patients are frequently required to manipulate biological drugs prior and during administration…
Thumbnail for CASSS Welcome and CMC Strategy Forum 2024 Introductory Comments
CASSS Welcome and CMC Strategy Forum 2024 Introductory Comments
Platform technologies are used extensively across the biopharmaceutical industry to develop drugs efficiently and effectively.  The application of prior knowledge and platforms from established products lays a strong foundation to guide development and advance new medicines to the patients…
Thumbnail for Workshop I: Established Best Practices for In-Use Stability Study Design and Testing
Workshop I: Established Best Practices for In-Use Stability Study Design and Testing
HOW TO DESIGN AND PERFORM IN-USE STABILITY AND COMPATIBILITY STUDIES?