Risk Management in ISO 13485
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue [...]
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue [...]
Design controls are a frequent citation in 483 observations and warning letters [...]
Documentation is a subject that comes up frequently in U.S. Food and Drug Admini [...]
In FDA and ISO environments, quality audits are a process of examination and sub [...]
Root cause analysis is a common weak spot in manufacturing, causing numerous qua [...]
Corrective and preventive action (CAPA) is a core function in any quality manage [...]
Finding the root cause of a manufacturing quality issue prevents unsafe or poor [...]
Imagine you’re doing a pre-shipment inspection on multiple pallets containing pr [...]
From Listeria in ice cream to E. coli in lettuce, there’s one central question i [...]
In recent months, the U.S. Food and Drug Administration (FDA) has issued a dozen [...]