Data Integrity
Data integrity has become a major focus of the FDA over the past few years. Violating data integrity guidelines has led to FDA warning letters, import alerts, and consent decrees. The FDA published a Data Integrity Guidance in December 2018 (see below).
Our experts can help your company prepare for an FDA Data Integrity inspection and we can help rectify on-going issues with this specialized training program.
This course can be customized to meet your company’s specific needs. You can select from our listed topics or if there are specific concerns at your organization, we can incorporate topics that are relevant to your team.
The training will include recent examples of FDA Warning Letters and 483s, as appropriate.
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SUGGESTED DATA INTEGRITY TOPICS
- Data Integrity - Definitions, Regulations and Trends
- Data Integrity GMP Requirements
- Warning Letters and inspection observations
- Areas impacted by Data Integrity
- How to ensure data integrity during GxP system development lifecycle
- Data Integrity Failures – Why and Where
- The Elements of Data Integrity
- Validation Paradigm Shift
- Data Integrity Review and Audit process