Cell culture media suppliers: regulatory considerations for advanced therapies
Learn more about regulatory challenges and opportunities in media production for cell and gene therapy.
Thursday 14 May 2020 07:00 [PDT] 10:00 [EDT] 15:00 [BST]
By choosing a media supplier that is prepared to partner with manufacturers through the raw materials qualification process and regional regulatory approvals, manufacturers can better address the challenges and opportunities on the road to bringing cell therapies to market.
What will you learn?
Regulatory requirements of different regions and how FUJFILM Irvine Scientific (CA, USA) helps the customer understand:
- How long the regulatory approval process takes in different regions
- Unique raw material qualification processes
- The importance of safety and timelines for choosing a media supplier for clinical trials
- How the right media supplier helps with media costs
Who might this interest?
- Pharmaceutical companies
- Cell and gene therapy companies
- QC and regulatory bodies
- Process development teams
- Translational and clinical companies
Senior Director of Quality Systems/Regulatory Affairs/Compliance Officer & ISO Management Representative
FUJIFILM Irvine Scientific, Inc.
Marlin Frechette has over 25 years of experience in the medical device industry, servicing pharmaceutical and biopharmaceutical customers. At FUJIFILM Irvine Scientific, she is currently the Senior Director of Quality Systems/Regulatory Affairs/Compliance Officer & ISO Management Representative. As part of her role, she manages and performs review functions of the Quality Systems, Global Regulatory/Product Compliance and Compliance/EHS departments. She holds a Bachelor of Science degree with a major in Business Administration & Personnel Management.