Cell therapy manufacturing and 21 CFR Part 11 compliance: Overview and considerations for instrument software
On demand

Cell therapy manufacturing and 21 CFR Part 11 compliance: Overview and considerations for instrument software

Thursday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST
Cell therapy manufacturing and 21 CFR Part 11 compliance: Overview and considerations for instrument software

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

When conducting cell therapy research or manufacturing process development, there is an emphasis on making sure the technical components are accurate: it is critical to ensure the science works, but it is equally important to maintain complete and accurate electronic records to allow for smooth regulatory submission.

In this webinar, we will share insights to help you better understand how electronic records and the requirements for 21 CFR Part 11 compliance are related. We will also discuss one option with which Thermo Fisher Scientific is enabling this compliance for cell therapy instruments through its SAE (Security, audit and signature) software. Having a system in place early during process development for electronic records and electronic signatures could save you time and effort as you transition to manufacturing.

  • Short overview of 21 CFR Part 11
  • Understanding options for instrument software for cell therapy development and manufacturing processes
  • Introduction to SAE (security, audit and e-signature) software
  • Learn about the CTS Rotea SAE software for cell processing using the CTS Rotea Counterflow Centrifugation System
Ashley Smith
Ashley Smith
Manager, Regulatory Affairs, Life Sciences & Laboratory Products Group, Thermo Fisher Scientific

Ashley D. Smith joined Thermo Fisher Scientific in 2021 as a Regulatory Affairs Manager in the Cell & Gene Therapy Business Unit. Her primary role is to serve as the regulatory lead on new product introduction teams, supporting both product development and customer use of the Cell Therapy Systems™ (CTS™) products. Dr. Smith began her regulatory affairs career as a product reviewer within CBER at FDA where she focused on Chemistry, Manufacturing and Controls (CMC) of biologic products. Upon leaving the FDA, Dr. Smith moved into the private sector where she contributed to the development and implementation of clinical, nonclinical, and CMC regulatory strategies at various-sized biotechnology companies in the fields of oncology and cell therapy. She holds a B.S. in Biomedical Sciences from Texas A&M University – Corpus Christi and a Ph.D. in Microbiology and Immunology from the University of North Texas Health Science Center.

Brianna Volk
Brianna Volk
Product Manager, Cell Therapy, Thermo Fisher Scientific

Brianna Volk joined Thermo Fisher Scientific in 2014 as a member of the Global Service & Support team providing on-site customer support across RUO, IUO, and IVD products. She joined the Cell & Gene Therapy team in 2020 to further support the establishment of Thermo Fisher’s Cell Therapy Systems (CTS) product line. As the Product Manager for the Gibco™ CTS™ Rotea™ Counterflow Centrifugation system, cell processing customer needs are regularly reviewed and evaluated for opportunities of easing customer-communicated workflow challenges. Brianna began her career in medical device development and later assisted with genetic research for addressing agronomical solutions before bringing her skills to Thermo Fisher customers. She holds a B.S.E. in Biomedical Engineering from University of Iowa.