Data Integrity 2021 - Establishing a Robust Data Integrity Program

Data integrity is defined as the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle. Data Integrity is a global issue with both FDA and the European Regulatory Agencies majorly focusing on the topic during compliance inspections.
The regulatory concern has been responded to by both domestic and foreign governing agencies with the FDA, EMA, MHRA, WHO, and PIC/S all having recently published data integrity standards and guidelines.
Problems with spreadsheets
Good Practice for using spreadsheets in a regulated environment
Building data integrity features into a spreadsheet
Speaker:
Ms. Kelly Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations.