Title 21 of the Code of Federal Regulations (CFR) Part 11 sets out the criteria under which electronic records are considered reliable and trustworthy.
Join us with compliance expert Christopher Buska, from Xybion Digital who will discuss Compliance Builder software from Xybion and how this can manage compliance across multiple platforms and harmonize compliance within your laboratory. Richard Cuthbert from Bio-Rad will be showcasing the powerful ZE5 Cell Analyzer and explaining why this innovative flow cytometer is a perfect fit for regulated laboratories.
Topics covered:
- How does Xybion’s Compliance Builder software support 21 CFR Part 11 compliance
- How can Compliance Builder harmonize compliance throughout your laboratory
- A detailed examination of the features of the ZE5 Cell Analyzer that make it ideal for regulated laboratories, especially those with high workloads
Christopher Buska
Product Manager & SME-CB,
Xybion Digital
Christopher is the Subject Matter Expert of Xybion’s CQRM Compliance Builder solution with over 15 years of experience supporting customers to provide coverage for auditing gaps with their laboratory instruments and digital processes. He is involved with all aspects of the implementation of Compliance Builder, from initial analysis of gaps to delivering and assisting in the formal validation process which regulated clients adhere to. Christopher initially joined Xybion as a C++ software developer designing user interface screens in Pristima, a technical background that he has leveraged successfully in managing client projects. He holds a BS in Computer Science from Stevens Institute of Technology, USA.
Richard Cuthbert, PhD
Global Commercialization Product Manager,
Life Science Group at Bio-Rad
Richard Cuthbert holds an honours degree in Biomedical Chemistry and a PhD in the field of regenerative medicine. Up until 2019 Richard worked as a Postdoctoral Researcher at the University of Leeds, United Kingdom where his main research interests were stem cell biology, rheumatology, and immunology. Richard joined Bio-Rad in 2019 as a flow cytometry specialist and is now a flow cytometry global product manager.