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A good data governance program will include aspects of computer system validation and maintenance, and also help identify the resources, processes and procedures needed to support the integrity, identity, authenticity, quality, and accessibility of your data. It is far more costly to lose sight of this and risk having data discarded or invalidated by FDA than it is to build a sound data governance program. We will also address 21 CFR Part 11, the FDA’s guidance on electronic records and electronic signatures (ER/ES).After attending this course, you will understand data governance as a quality control discipline for assessing, managing, using,
improving, monitoring, maintaining, and protecting organizational information.
Key Learning Objectives
- Discuss the best practices necessary to ensure all systems are validated appropriately
- Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk
- Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state
- Learn how to develop a strategic approach to data governance to ensure data integrity, quality, identity, accessibility, and security
- Q&A
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Carolyn Troiano
IT/Business Leadership Professional
Carolyn has more than 35 years of experience in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.
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