Meeting Modern Data Integrity and Compliance Requirements

Wednesday 13th September, 10:00am EDT / 3:00pm BST / 4:00pm CEST



Industry faces the everyday challenge of managing cost efficient operations, producing high quality, safe products and having visibility of the operations and data. Ensuring the cost of quality adds value to the operations, becoming lean, streamlined, improving process and complying with the industry regulations are at the top level priorities.

In recent years, the FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry's responsibility to ensure the safety, efficacy, and quality of drugs, and of the FDA's ability to protect the public health. These data integrity-related CGMP violations have led to "numerous regulatory actions, including warning letters, import alerts, and consent decrees."

(Source: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm495891.pdf )

Attend this webinar and learn more about:
  • Defining Data Integrity (DI)
  • Why Data Integrity is important
  • How you can meet data integrity requirements
  • How to increase paperless workflows
  • How to improve your laboratory insights
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Tony Martin
Senior Global Manager
Abbott Informatics
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