Pharmaceutical Data Integrity

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.

Why Should You Attend:

Human error is known to be the major cause of observations from regulatory agencies, quality deviations, and production losses in many organizations. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges in a GMP environment it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed.
This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

Why Should You Attend:

In their guidance on data integrity, all regulators emphasize a risk-based approach to ensure that effort is focused on the greatest risks. This approach should help companies to achieve compliance with regulators’ expectations without committing a disproportionate amount of human or financial resource. This webinar will explain to attendees why data integrity is so important and spell out some of the common honest mistakes that could lead to regulatory enforcement action. The risk-based approach recommended by regulators is also explained in detail.

Areas Covered in the Webinar:

• Data integrity myths
• Historical background
• Definition of data integrity
• Current regulatory approach
• Guidance
• Static and dynamic records
• Non-conformance trends
• Example enforcement letters
• Data integrity risks in the analytical process
• Conducting a data integrity risk assessment
• Common causes of data integrity breaches
• Practical tips on achieving compliance

Instructor Profile:

Mark Powell
Director, Mark Powell Scientific Limited

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. 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.