Data Integrity: FDA Enforcement and Risk-Reduction Considerations On-Demand Webinar

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Recorded March 13, 2018 | On-Demand Webinar

In 2017, more than 60% of FDA warning letters cited data integrity issues. Potential regulatory risk from data integrity problems extends far beyond laboratory notebooks and computer system audit trails. This must attend webinar will delve into critical data integrity considerations, including FDA’s new warning letter language and the expectation it creates for manufacturers; the Application Integrity Policy (AIP) – the original remedy for data integrity issues; and clinical data management problems across clinical data contract service providers and how to adequately address these problems. Attendees will hear from two of FDA’s leading experts on data integrity, along with industry experts who have deep knowledge in resolving data integrity challenges. Attendees will have ample time to ask questions of the panelists – including FDA.

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