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Webinar: Data Integrity as an Indicator of Other Quality Control Issues

Presented by subject matter expert Mark Newton, Quality Assurance Professional & Owner of Heartland QA

Due to numerous and severe regulatory findings, companies have all boarded the data integrity train and started remediating their automated systems, developing checklists, process flowcharts, and risk registers. But what if data integrity is not the real problem, but a result of another issue? This presentation will share experiences from a site where this was the situation – data integrity was the symptom of deeper issues.  



The presentation will share facts observed and how those facts came together to reveal the root issue—an issue likely shared at many companies. How do Process Engineering, Sales and Marketing, Analytical Development, and Process Development create data integrity issues in the QC Laboratory? This presentation wants you to re-think what you know about data integrity remediation.

Presented By 

Mark Newton_headshot


 Mark Newton, Quality Assurance Professional, Owner of Heartland QA

 Professional Associations:

         - Member, ISPE and GAMP Community of Practice (CoP)
         - Member, Parenteral Drug Association. Committee member for 2021 Data Integrity Conference
         - Chair, ISPE Global Documents Committee (2017-2019); currently committee member
         - Co-Lead, ISPE/GAMP Data Integrity Special Interest Group (Jan 2014-2021)
         - Co-Lead, ISPE/GAMP Laboratory Special Interest Group (2011-2013)