Pharmaceutical Data Integrity

Mark Powell

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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:

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

Who Will Benefit:

  • Quality assurance professionals
  • Consultants
  • GMP auditors
  • Laboratory management
  • Contract laboratories
  • Personnel responsible for data review
  • From Pharmaceutical manufacturers, contract laboratories
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

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Recorded video

Recorded video session

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Speaker: 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. 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.