As regulators are focusing their inspection on data integrity, it is important that managers, supervisors, and users in regulated GMP laboratories understand the issues relative to data integrity and implement robust programs to ensure compliance.
1. Regulatory Guidance Review
2. Review all Elements Important to Maintaining Data Integrity
3. Key Data Integrity Topics
4. What are GMP-relevant Data?
5. Why Is An Audit Trail Review Important?
6. Can Spreadsheets meet Data Integrity requirements?
7. Common problems from FDA 483 observations and warning letters and how to avoid them
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. Multiple FDA warning letters and EU GMP non-compliance reports have highlighted major data integrity failures and falsification within companies around the globe. 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.
This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems.
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.