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...

This article suggests right-sizing need and costs: variable outsourcing of Quality and Regulatory leadership to best match needs and spending.

Download our Free Combination Products Poster This "Lessons Learned from Combination Products" poster was presented at the Parenteral Drug Association's (PDA) Annual Meeting. Learn about the what, when, and how...

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....