FDAnews Announces -- Data Integrity: Latest Regulatory Developments and Best Practices Webinar, Jan. 14, 2020

FALLS CHURCH, Va., Dec. 30, 2019 /PRNewswire-PRWeb/ --
Data Integrity:
Latest Regulatory Developments and Best Practices
An FDAnews/CenterWatch Webinar
Tuesday, Jan. 14, 2020, 1:30 p.m.-3:00 p.m. EST a good quality system in place to ensure data integrity? The FDA consistently communicates the importance of supporting data integrity. One needs to know when one is required to report significant data integrity issues discovered pre-submission and the advantages of early disclosure to the FDA a?? even when no early disclosure obligation exists.Join us for a webinar on Jan. 14 and be ready to tackle any challenges that come up and help companies stay in compliance with the FDA. During the workshop, attendees will:

Get an overview of FDA's expectations for data integrity, including the statutory and regulatory basis for those expectations

Review key guidances governing data integrity concepts in both the GMP and GCP context

Familiarize oneself with FDA's recent regulatory actions addressing data integrity issues, including warning letters, import alerts and injunctions

Determine best practices to use in responding to questions FDA raises concerning data integrity, such as ensuring a systemic response to deficiencies and using independent third-party auditors

Determine the quality by design principles to follow in order to ensure quality and avoid data integrity issues, including identifying key resources

Attendees will gain practical tips for how to build a quality system and gain insight on FDA guidance on data integrity.
See also:
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