Resources

A landmark FDA consulting article in Pharmaceutical Technology, “Linking Drug Shortages and Quality Metrics” provided information regarding the link between drug shortages including the enactment of the Food and Drug...

Susan Schniepp, Distinguished Fellow of Regulatory Compliance Associates® Inc., discusses how the FDA's proposed guidance for the metrics of quality raises questions about quantifying the tangibles and intangibles of quality...

A risk assessment should be performed as part of the CAPA quality process, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates. Q: How much data do I need...

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to method validation and validating analytical methods....

Consider these common FDA registration scenarios: an acquisition or carve-out occurs, and a medical device has a new manufacturer, or a manufacturer decides to change its name as a result...

Among the current and emerging topics of interest to the pharmaceutical industry, the topics of quality metrics, quality culture, and data integrity are of particular concern to both the industry...