Data Integrity: FDA/EU Requirements and Implementation
Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.
(10:00 AM to 5:00 PM EST)
Virtual Seminar
Data integrity has been a focus for pharmaceutical regulatory inspections for a number of years and look set to remain of concern to regulators and manufacturers for many years to come. Many inspection reports from regulatory agencies around the world cite data integrity as a cause of observations and enforcement action, and actions taken by regulators to restrict the commercial activities of manufacturers on the grounds of data integrity violations have obvious serious consequences for the company concerned.
This 2-day on-line course explains the background to the data integrity regulations and sets out the expectations of pharmaceutical regulators. All the current data integrity guidances emphasise a risk-based approach to compliance, and the course explains how to evaluate and control data integrity risks. A key resource in relation to electronic records is GAMP 5, which deals with controlling risk and managing computerised systems over their life cycle. The practices recommended by GAMP 5 will be dealt with in detail, and practical advice on the appropriate use of Excel spreadsheets given. Data integrity should not be thought of as an exclusively analytical problem, and examples of data integrity violations in production will highlight the risks during manufacturing.
Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty 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, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.