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According to a recent article in the American Pharmaceutical Review, “In 2020, numerous warning letters were issued from the FDA citing data integrity violations. Common findings violate principles of ALCOA+, 21CFR Part 11 and the FDA’s data integrity guidance document. Additional findings include deletion or manipulation of data, aborted sample analysis without justification, invalidated OOS results without justification, failure to document work contemporaneously and uncontrolled documentation." If you need help navigating the complex and evolving inspection landscape or are concerned about remote inspection requirements due to the pandemic, please join us for this live webinar where we will share expert insights and will address your compliance and data integrity concerns.
In this webinar, you will have the opportunity to question Waters’ leading experts in Empower Software, in data integrity, and in regulatory compliance. Waters understands how important these topics are for regulated companies and have supplied a list of additional resources below. All questions are welcomed during the webinar, and reviewing some of the linked materials before the webinar may help you to construct in-depth questions to really challenge the experts and substantially improve your own knowledge about how Empower supports compliance.