PDA Metro Chapter Webinar: Data Integrity based on TR84
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Expectations around data integrity are not something new to our industry. The FDA issued 21 CFR Part 11 in 1997 to establish the criteria for the use of electronic records and electronic signatures in complying with predicate rules. As early as 2000, a warning letter was issued citing lack of control over computerized laboratory systems. While progress has certainly been made in the intervening 20+ years particularly in QC Laboratories, the basic expectations are still often found to be deficient within the manufacturing space and the need to evaluate the risks in the research and development space appears to have been overlooked by many. Leveraging the new PDA TR, this session will revisit the expectations and particularly the opportunities to ‘build in’ data integrity elements in manufacturing to succeed in this mission.
Speaker Information:
Anne Pericone, MBA, Director Quality Systems Integration, Johnson & Johnson
More information coming soon.
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