Meet regulatory compliance for biopharma with new mass spec software solutions
Data integrity plays a key role in ensuring the quality and safety of biopharmaceutical products. In this webinar, explore the current regulatory landscape and how new mass spectrometry software updates can enable you to address data integrity and meet regulatory requirements, such as US FDA 21 CFR Part 11 and EU Annex 11.
Learn how advanced security features and built-in technical controls minimize security risks when applied to workflows for the analysis of intact proteins, protein digests and released glycans, by enabling setup of user roles, user permissions, audit trails, checksums, and secure content management across all software modules.
Learning Outcomes:
- Learn about the current regulatory landscape
- How to address regulatory compliance and data integrity using technical controls
- Adopting LC/(Q)-TOF in a regulated environment
- How Agilent’s new version of MassHunter Acquisition and BioConfirm software can help you meet regulatory requirements, such as US FDA21 CFR Part 11 and EU Annex 11
Who should attend?
- Lab managers
- Validation and QA/QC managers
- Biopharma analysts
- IT professionals supporting biopharma labs
Presenter: Robert Ley (MassHunter Compliance Software Product Manager, Agilent Technologies)
Robert Ley is the MassHunter Compliance Software Product Manager. He has been with Agilent since 1997 and hasheld multiple roles such as a Field Service Engineer, Product Support Engineer, and Global Support Manager. He has been passionate about mass spectrometry and its powerful scientific insights since 1993.
Moderator: Sarah Thomas (Editorial Team, SelectScience)
Sarah studied biology at the University of Bath, UK, and has worked in the Pharmaceutical Sciences Department of St. Jude Children’s Research Hospital, Memphis. As a member of the Editorial team, Sarah plays an integral role in shaping the content on SelectScience.
