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Data Integrity: Best Practices for Compliance and Maintaining a Culture of Quality
Regulatory guidelines link data integrity with a culture of quality. Does your organization understand how best to manage your data? It must be compliant — maintaining a culture of quality — or you’ll face the consequences of ignoring the rules of documentation.
This presentation will explain high-level data integrity concepts, the definition and importance of data integrity, regulatory expectations for preventing data integrity issues, problem areas for data integrity and strategies for detecting potential data integrity issues in your operations.
Learn how to control your data, avoid integrity issues and improve your organization.
Susan J. Schniepp, a Distinguished Fellow at Regulatory Compliance Associates, Inc., is a pharmaceutical quality assurance thought leader with 40 years of experience. She has held leadership roles in the industry at Allergy Laboratories, Inc.; OsoBio Pharmaceuticals, LLC; Searle; Abbott and Hospira. Ms. Schniepp is a member of the PDA Board of Directors and has served as the PDA/FDA Joint Regulatory Affairs Conference Chair, conference presenter and Chair of the PDA’s Regulatory Affairs/Quality Advisory Board.
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