Tougher Quality Management Enforcement Possible by FDA
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.
Sean Doering, a 2016 graduate, and Associate Professor Jen Grant discuss Doering’s research conducted in the Student Jobs Program.
Credit: UW-Stout
Context. What the heck is that and how do you apply the term to your organization?
Credit: Takako Tominaga
One of the newest parts of ISO 9001:2015 and related management standards are the concepts of context and interested parties. What do these mean, and how can you apply them to your organization?
Can you imagine trying to do CAPA faced with this?
Credit: Dave Wilson Cumbria
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For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern.