US Food and Drug Administration Regulatory Pathways
Over the past five years, the medical device industry has witnessed an explosion of new and innovative...
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Data Integrity and Quality Culture
In this episode, host Erika Porcelli is joined by Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates...
The Metrics of Quality Culture
The long-awaited and anxiously anticipated FDA guidance on quality metrics was finally distributed for comment on July...