Presentation Eli Lilly
Presenter´s biography
Mark Newton has been employed for 33+ years by Eli Lilly and Company in several cross-functional roles. Starting as a Microbiologist, he spent 14 years within the chemical, pharmacological, and microbiological areas of QC Laboratories as an analyst, method developer and supervisor. The balance of his career has been within IT and Quality, implementing GMP software, serving as computer system QA, then a Laboratory Data QA representative, developing standards for qualification of laboratory computerized systems and training lab personnel in data integrity auditing, gap identification and remediation techniques.
He is co-editor of the GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (2nd ed), and currently co-leader of the GAMP Data Integrity Special Interest Group (SIG) and the ISPE Global Documents Committee. He has recent publications in Pharmaceutical Engineering, Scientific Computing and the ISPE Blog (ISPEAK).
Abstract
Chromatography data is central to most laboratory operations. Unfortunately, even with a restrictive configuration and procedural controls, there are a number of ways for laboratory analysts and reviewers to manipulate chromatography systems to make tests or tested articles appear to be better than their true condition. It is imperative that companies establish analytics and review practices that are able to detect and prevent such improper manipulations.
Presentation will offer some examples of improper manipulation, discussing their motivations and detection. Some examples will be obvious and others, subtle. Examples will be based on Empower CDS, but will be applicable to majority of other systems as well.
Company Introduction
We were founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that met real needs in an era of unreliable elixirs peddled by questionable characters. His charge to the generations of employees who have followed was this: “Take what you find here and make it better and better.”
More than 140 years later, we remain committed to his vision through every aspect of our business and the people we serve starting with those who take our medicines, and extending to health care professionals, employees and the communities in which we live.
