ISCT Webinar: Utilizing a Risk-Based Approach for the Development of Media Used in Cell Therapy Applications
Sponsored by Irvine Scientific
Date: Wednesday, June 17, 2015
Time: 9:00 AM PT, 12:00 PM ET, 5:00 PM BST,6:00 PM CEST
Chair: Jayme Yamaguchi-Owens, Senior Manager of Regulatory Affairs, United States
Speaker: Marlin Frechette, Quality Systems/Regulatory Affairs & Management Representative, Irvine Scientific, United States
About the Webinar:
There have been numerous occurrences of contamination in biologics by adventitious agents over the years. As a result of these events, regulatory bodies and manufacturers such as Irvine Scientific have developed strict controls and processes that mitigate the risks of contamination. In this webinar we will present how utilizing a risk-based approach for media development ensures consistency, quality and facilitates scale-up transfer to clinical applications.
Topics covered will include:
- Quality by Design (QbD)
- Raw material qualification
- Supply chain management
- cGMP manufacturing
- Cold chain logistics
About Irvine Scientific:
Irvine Scientific is a worldwide leader in the design, and production of cell culture products for cell therapy, immunology, biopharmaceutical, cytogenetic, and ART applications. Our extensive experience with media design, cGMP manufacturing and compliance with ISO and FDA regulations uniquely positions us to support cell therapy applications from basic research through scale-up and to the later stages of clinical development.