Here at Bio-Rad, we are dedicated to bringing you the tools you need to push the boundaries of what is possible and turn today’s inspiration into tomorrow’s medicines. If you are considering progressing your research into an environment that requires regulatory compliance, you need to be aware of 21 CFR Part 11 regulations.
Join us for an introduction to 21 CFR Part 11 by Christopher Buska from Xybion Digital. Xybion’s Compliance Builder software provides 21 CFR Part 11 support with minimal system and operator changes, including audit trail time stamps and data security. It can be used with the ZE5 Cell Analyzer to bring the power and speed of the ZE5 Cell Analyzer to regulated environments.
Find out:
- The history of the regulatory framework
- What the primary requirements are for complying with 21 CFR Part 11
- What the ALCOA+ Principle is
- How Xybion’s Compliance Builder software supports compliance
- Why the ZE5 Cell Analyzer is a good choice for compliant flow cytometry workflows
Christopher Buska
Product Manager & SME-CB,
Xybion Digital
Christopher Buska is a graduate of Stevens Institute of Technology with over 16 years of experience in the field of software development for preclinical lab management solutions to pharmaceutical and clinical research organizations. He has extensive expertise in regulatory compliance solutions that work within an organizations existing infrastructure to achieve 21 CFR Part 11 compliance.
Richard Cuthbert, PhD
Global Commercialization Product Manager,
Life Science Group at Bio-Rad
Richard graduated with a Bachelor of Science in Biomedical Chemistry in 2000 and obtained his PhD in regenerative medicine at the University of Leeds in 2014. He was a Post-Doctoral Researcher at the University of Leeds from 2014-2019, where his primary research interests were stem cell biology, rheumatology, and immunology. He joined Bio-Rad as a Regional Flow Cytometry Specialist in 2019 and is now Product Manager for the ZE5 Cell Analyzer.