Wednesday, 27 February 2018, 11:00 AM-12:00 PM EST
NERCSQA Chapter Webinar Series: Management Culture & Data Integrity Governance Programs
Presented by: Monica Cahilly
Please note that the presenter did not release this webinar for recording.
Data Integrity continues to prove a complex, global challenge for both regulators and industry. Many companies are writing Data Integrity Compliance Plans and launching Quality Culture initiatives and/or implementing computer system improvements to enhance data integrity assurance. But are these efforts appropriate, cost-effective, and adding meaningful value to the quality and reliability of our GXP data? This presentation will discuss the varied solutions being explored to "solve" the data integrity challenge, including holistic Management Governance and Quality Culture and Data Governance initiatives to align with the modernization of the FDA’s and other Health Authorities’ current global regulatory expectations and industry standards for data integrity assurance. The discussion will include specific considerations for preventing and detecting data integrity risks in GXP data and underlying dependencies for program effectiveness.
RQAP Re-registration units:
0.25 GCP or GLP