510K

Application number that medical device manufacturers must file, to notify FDA of their intent to market a medical device at least 90 days in advance. Also known as Premarket Notification – PMN. This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, … Read more

5S

Japanese method for workplace organization. The five S’s are seiri, seiton, seiso, seiketsu, and shitsuke or sorting, straightening, shining, standardizing, and sustaining. The picture shows a 5s organized tool system. Every tool has it’s place and if it is not there it is obvious.      

API

Active Pharmaceutical Ingredient

APR

Annual Product Review

AQL

Acceptance Quality Level (Limit)

CAPA

Corrective Action Preventative Action – This is a process for correcting and preventing errors during a procedure. A corrective action may be implemented as the result of a non conformance or deviation. The corrective action may be a document change, training, or any documented activity that is designed to stop the re-occurrence of the deviation. … Read more

CBER

Center for Biologics Evaluation and Research

CDER

Center for Drug Evaluation and Research

CDRH

Center for Devices and Radiological Health

CFR

Code of Federal Regulations governs manufacturing requirements per the FDA.