Keynote Presentation

Presenter: Mark Newton, principal at Heartland QA 

Mark is an independent consultant who specialises in data integrity, laboratory informatics, computer systems validation, and Quality.

He has 35 years of experience in the pharmaceutical industry in QC Labs, computer systems validation and lab informatics at Eli Lilly. 

Mark co-lead Eli Lilly’s data integrity remediation program for QC Labs worldwide in 2012, consulted and audited several Lilly sites preparing for data-integrity focused inspections.

Mark is a co-leader for the GAMP Data Integrity Special Interest Group and Chair of ISPE Global Documents Committee.
Co-author of "Harmonizing USP <1058> and GAMP for Analytical Instrument Qualification"  Schuessler, Newton, Smith, Burgess, McDowall. Pharm. Engineering, Jan/Feb 2014
Co-editor of the GAMP Good Practice Guide "A Risk-Based Approach to Compliant Computerized Laboratory Systems" Nov. 2012.

Abstract

We have blind spots in our thinking and our Quality Systems.

We will use a Dissolution assay to illustrate the way that we can be misled with summary information to believe a product is acceptable. Then, we will see how to use simple techniques and metadata to discover possible issues in that data, and to finally understand the true situation.

The presentation will end with a discussion of statuses, and how they can become powerful tools to assess the quality of data in an organization.

Participants will leave with a set of tools they can apply to data wherever it is found.