Why Do FDA Inspections Often Turn Out Bad?

Why do good manufacturing operations have bad inspections? FDA warning letters and 483s are rife with references to manufacturing controls and batch failures; to SOPs and QC procedures; and to complaint handling and CAPA investigations. But in many,... Read more

The Winchester House of Quality

Well designed and executed quality systems are the foundation of compliance for the highly regulated pharmaceutical and medical device industries. Still, many companies struggle to build strong, functional quality systems, instead creating various regulatory versions of the Winchester... Read more