Data Integrity for Pharmaceutical Chromatographers
Data integrity has been the subject of increasing scrutiny during pharmaceutical regulatory inspections in recent years.
Chromatographic data systems have received particular attention because of the potential for data manipulation to produce fraudulent data, or uncontrolled changes in processing parameters that compromise the comparability of results between runs.
This webinar explains the intention behind data integrity regulations, sets out current expectations and suggests an approach to compliance based on sound science.
Presented by: Mark Powell -Independent Data Integrity Consultant
Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over 30 years’ experience as an analytical chemist.
Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016. In 2003, he joined a contract research and manufacturing organisation specialising in early stage drug development, where he set up the analytical facility and managed the analytical development programme. During his time in the pharmaceutical industry, Mark was responsible for commissioning and validating several chromatography data systems. In 2013, he set up his own company which offers training and consultancy services to industry.
Services include guiding the analytical aspects of drug development programmes, technical training in areas such as chromatography and dissolution testing, and data integrity training and auditing.