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Validity : 10th May'24 to 20th May'24
Data Integrity Fundamentals
- Become familiar with the regulatory agencies’ perspective of Data Integrity
- Understand the meaning of Data Integrity
- How data integrity manifests itself?
- What are the factors that affect Data Integrity?
- What are the attributes of Data Integrity?
- Review some recently issued 483s and Warning Letters on Data Integrity
Overview of the webinar
The biopharmaceutical industry finds itself under increasing pressure to focus on Data Integrity (DI). Auditors require companies to ensure that appropriate DI controls are implemented and appropriately managed throughout the data lifecycle. While industry comes to grips with the complexities of data integrity in their global supply chain, a series of webinars on DI are planned to assist your understanding on how to identify data integrity problems in your company and the steps you need to take to remediate them. Each webinar is designed to address a specific DI issue such as how to establish a corporate DI program, where does DI fit in the data lifecycle, mapping DI to existing predicate rules and how to design for DI during SDLC etc.
This is the first webinar in the series. It addresses DI concepts, fundamentals and their attributes. This understanding is essential for the uncovering of potential DI problems in a company.
Data integrity has been at the forefront of the recent news. Regulators are increasingly focusing on data integrity. Audits are unraveling data integrity vulnerabilities arising from data loss during transport and data corruption during data storage and recall.
Establishing data controls is a key to ensuring data integrity. The onus is on the system users to understand and use existing regulations such as CFR 21 Part 11 and Annex 11 to design system controls to detect and document all data changes to make them trustworthy. Subsequently, the designed systems must be validated by taking into consideration all aspects of data integrity.
Who should attend?
- Manufacturing Engineers
- Research Scientists
- Manufacturing Supervisors and Floor Personnel
- Quality and Validation Group
- Business Process Managers
- IT Group
- Regulatory Business Group
Why should you attend?
This webinar demonstrates the fundamental aspects of data integrity and the specifics of data integrity attributes. This understanding is essential to understand the more complex issues of data integrity that will be the topics of future webinars.
Faculty - Mr.Chinmoy Roy
Chinmoy Roy is an internationally recognized Subject Matter Expert (SME) in the areas of GAMP, Data Integrity, CFR 21 Part 11, Annex 11 and Quality Risk Management. An engineer, with over 35 years of experience in major US biopharmaceutical companies, he has successfully installed and validated over 200 IT systems in the biopharmaceutical industry. His practical experience along with case studies enables him to answer trainee specific questions, thereby providing them the background to take their learnings back to their work and use them immediately. His training stresses critical thinking from first principles of compliance regulations. He has been invited to present and conduct workshops at several professional conferences worldwide. He has been a member of discussion panel member along with FDA personnel to discuss data integrity issues and also as a speaker on “Data Integrity Quality Issues” as invited keynote speaker at worldwide conferences.