JD Supra

Navigating FDA’s Guidance on Validation and Verification of Analytical Testing Methods for Tobacco Products

The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides ...
RAPS

Medical Device Validation: What You Need to Know and Why It's Important

Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max ...
RAPS

FDA officials: Consider a master validation plan for process validation during inspections

COLUMBUS, OH – Having a master validation plan in place will help inspectors identify validated and verified activities during an inspection at your company, according to US Food and Drug ...
technologynetworks

Regulatory Considerations for Clinical Proteomics in Diagnostic Laboratories

The successful translation of biomarker discoveries into actionable diagnostic tools requires strict adherence to the robust regulations governing clinical proteomics. As mass spectrometry and ...