Data integrity is a critical component of pharmaceutical product quality and the information submitted 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, United States 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 60-minute webinar will look at the criteria for data integrity, the recent guidance issued by both the 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.
During this webinar, attendees will learn the current regulatory position on data integrity; discover the criteria for data integrity; recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory; and learn about approaches to improve data integrity in a laboratory environment.
This webinar will be hosted by Pharmaceutical Technology on May 27, 2015 at 11:00 EDT (15:00 GMT). Register for the live webinar at: www.mt.com/lab-data-webinar
https://www.mt.com/content/us/en/home/supportive_content/press-releases/webinar_data_integrity_gxp_regulated_lab.html