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Implementation and Management of GMP Data Integrity - Webinar

2017, December 12

Pharmaceutical » Webinar


Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records.


In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, biologics and medical devices. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. Attendees will obtain an understanding of the Regulatory expectations for Data Integrity. The information provided at the webinar will enable the attendees to review practices at their own site and identify gaps in their own practices.


• Examples of data integrity pitfalls
• Part 11 compliance data integrity issues
• Review of FDA citations related to data integrity


Quality Assurance/Quality Control Directors, Managers, and Specialists
Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
Engineering/Development Directors, Managers, and Specialists

1. Understand the current regulatory position on data integrity
2. Discover the criteria for data integrity
3. Recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory
4. Learn about approaches to improve data integrity in a laboratory environment
5. Part 11 compliance
6. FDA citations related to data integrity issues

For more detail please click on this below link:


Internet - webinar


Phone: +1-720-996-1616
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