Culture of Quality and Compliance Go Hand in Hand, Says Expert

Focusing on fostering a culture of quality in a drug manufacturing company seems obvious today — a given. But that wasn’t always the case, explained industry veteran Sue Schniepp, a distinguished fellow at the consulting firm Regulatory Compliance Associates.

The intense focus on the culture within a drug manufacturing company and whether or not that culture is leading to quality processes and products really accelerated that moment in 2013 when the FDA announced it would begin collecting metrics from manufacturers as a way to assess the depth of their compliance issues, compliance issues the agency suspected were the cause of the bad drug shortage at the time, said Schniepp, who has penned books on the topic.

“The thought was: we can provide you all the metrics you want but you’ll never really know if these are our true numbers if you don’t know the culture behind the metrics,” she told FDAnews in an interview.

Learn more from Sue Schniepp at her upcoming presentation “Building a Culture of Quality,” at the GMP Quality Management vSummit 2023 produced by FDAnews, a WCG company, Oct. 11-12.

Register for the GMP Quality Management vSummit here.

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