Presentation HeartlandQA

Name:             Mark Newton

Title:               Principal

Company:    HeartlandQA

Presenter´s Biography

30+ years of experience in pharmaceutical manufacturing. During my career, I designed and supported LIMS systems, standalone lab instruments, lab informatics and metrics, validation, quality systems, and data standards. I have been deeply involved in data integrity since 2011, co-developing and delivering data integrity training to people in QC Laboratories, Manufacturing, and IT. I was co-editor of the GAMP Good Practice Guide "A Risk-Based Approach to Compliant Computerized Laboratory Systems", released Nov. 2012. I was an author team member for the GAMP Records and Data Integrity Guide released in April, 2017. Since 2014, I have been a co-leader of the ISPE/GAMP Data Integrity Special Interests Group (SIG).

Mark Newton has also presented at #PLA2017 Presentation EliLilly:“Manipulating Chromatography Data” (for Fun and Profit)

Abstract

Evidence suggests that the amount of fraud in research publications is larger than is detected.  Drawing comparisons between the large number of data integrity issues found by drug inspectors, a case can be built to conclude that data integrity problems are far larger than anyone is willing to report.  This presentation lays out the comparison between drug manufacturing and research, so the audience can draw their own conclusion.  If correct, this issue will result in significant changes in the way research data is collected, processed, and retained.