ON-DEMAND WEBINAR | Data Integrity Concerns: Challenging Chromatographic Analyses

Library Number:
Content Type:
On Demand Webinar
Content Subtype:
Compliance and Regulatory
Related Products:

Webinar Overview:

Chromatographic analyses (such as impurities analysis, relative substance analysis, or stability indicating methods) rely on skilled analysts to accurately integrate challenging chromatograms and often require complex calculations.
The iterative process needed for accurate measurement and quantitation of low level components may be misinterpreted as evidence of data manipulation. In addition, calculations may require component designations to ensure only true impurity peaks are included in final results, excluding, for instance, system peaks. 

Impurity calculations today may be performed in spreadsheets, electronic lab notebooks, or LIMS systems, which require transfer of data. This data transfer must meet compliance expectations to ensure complete and error-free transmission. 

Users of the Empower CDS may take advantage of tailored calculations to automate many calculations in the CDS, eliminating the challenge of data transfer. In this webcast, viewers will be reminded of the impurity processing capabilities of Empower, including an automated way to calculate ICH impurity values, without the need to export data or leverage Custom Fields.

Key Learning Objectives:

  • Why impurity methods present challenges with regards to Data Integrity
    • Addressing integration challenges
    • Regulatory concerns about suppressing peak integration and the use of spreadsheets
  • Alternative approaches to calculating impurity results
  • Learn about the Empower ICH Impurity Processing capabilities
    • Identifying component designations for impurity results
    • Impurity response
    • Setting reporting thresholds
    • Results and reports
    • Dealing with multiple APIs
  • Appreciate the benefits of MS detection in impurity analysis

Who Should Attend:

  • Regulated companies (pharmaceutical, food, environmental)
  • Laboratory directors, managers, and analysts
  • Information technology professionals supporting laboratory applications: managers, business system analysts
  • Quality Assurance professionals


Neil Lander  Heather Longden  Ethan Castillo 
Neil Lander
Principal Product Manager, Informatics    
Waters Corporation
Heather Longden
Senior Marketing Manager
Informatics & Regulatory Compliance     
Waters Corporation
Ethan Costello