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.


PRESENTATION

Elevating Your Change Variant and Aggregate Analysis for Biotherapeutic Proteins
WHAT YOU
WILL LEARN
  • 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


PRESENTED BY
Robert Ley
MassHunter Compliance Software Product Manager
Agilent Technologies