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On Demand Webinar
LabX: Importance of Data Integrity in a GXP Regulated Laboratory
Data integrity is a critical component of pharmaceutical product quality and the submission information to regulatory agencies. However, in recent years an increasing number of inspections have revealed incomplete data, the lack of audit trails, and falsification of results.
In July 2014, US Food and Drug Administration (FDA) issued a stern warning that data integrity was a key focus of its enforcement efforts. The UK Medicines and Healthcare Products Agency (MHRA) went further and issued GMP Data Integrity Definitions and Guidance for Industry in January 2015.
As regulators continue to tighten their inspection approaches, it is critical for managers and scientists in regulated GXP laboratories to understand the key issues surrounding data integrity and be able to demonstrate compliance.
This webinar will look at the criteria for data integrity, the recent guidance issued by both FDA and MHRA, and the regulatory citations for non-compliance. The presentation will include areas for assessment and improvement in data integrity, such as what constitutes raw data when a computerized system is involved. Practical solutions to improve data management processes and address data integrity weaknesses in a typical laboratory will be discussed.
Key Learning Objectives:
This webinar will be of interest to: