Resources

As Quality Maturity evolves based on the FDA's metrics strategy, it was documented the agency wanted "a maximally efficient, agile, flexible, pharmaceutical manufacturing sector. The goal included high quality drug...

A proposal for applying GMPs to development projects, which is consistent with FDA’s proposals on a "graded" approach in developing and building scientific information to support clinical investigations and industry...

Q: I am a quality professional in charge of investigations. Sometimes our company has trouble coming up with the root cause for some of our investigations. Can you provide some...

As the pharmaceutical market continues to expand globally, regulatory affairs in pharma is making an effort to harmonize global standards and to protect the complex supply chain. Pharma companies and...

Building a Culture of Quality for Increased Success In this webinar, Susan Schniepp, distinguished fellow at Regulatory Compliance Associates (RCA)®, will explain why quality culture is a must; new quality culture...

Products must be manufactured by following guidelines and in accordance with appropriate medicine manufacturing regulatory requirements, even during a pandemic and crisis management, says Susan J. Schniepp, Distinguished Fellow, Regulatory...