The US Food and Drug Administration (FDA) has warned an active pharmaceutical ingredient (API) maker in India for falsifying manufacturing records and issued a warning letter to a contract testing lab ...
As emphasis grows on managing data in pharmaceutical labs and plants—collecting and storing it, sharing it, mining it for pertinence—a basic question often goes unanswered: Is the data any good? The ...
Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to medical devices. Over a year ago, FDA’s device center, the ...
Chris is the CTO and Co-Founder of Scientist.com, a Research Platform helping drug discovery researchers develop new therapies. The FDA’s adoption of electronic submissions raised concerns about data ...
Key market opportunities include gaining expertise in FDA compliance for computer system validation, implementing robust risk-based validation strategies, and addressing challenges in cloud, AI, and ...
Increased regulatory focus on data integrity violations in GxP inspections opens opportunities for pharma companies to invest in staff training and compliance strategies related to document management ...
SUNNYVALE, Calif.--(BUSINESS WIRE)--#DvSum--DvSum, a leader in data intelligence management, is pleased to announce its partnership with Booz Allen Hamilton and the U.S. Food and Drug Administration ...
This seminar presents a market opportunity for professionals and businesses needing to enhance their understanding of FDA compliance, particularly in computer system validation. It focuses on risk ...
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