FDA inspections of biopharmaceutical manufacturers often lead to the discovery of avoidable compliance issues.

On today’s episode, Staying Ahead of the Curve in BioPharma: Navigating FDA Inspections, Drug Supply Chain Security Act (DSCSA) Implementation, and Supply Chain Disruptions, we discuss tips for avoiding common compliance issues discovered during FDA inspections and explore the upcoming implementation of the DSCSA and its impact on supply chain stakeholders. From new technologies to processes for product tracing and verification, we'll cover the strategies you need to prepare for this important legislation. Additionally, we'll discuss the importance of being prepared for supply chain disruptions and how onshoring and near-shoring may provide solutions.

Questions & Comments: wkirton@bakerlaw.com; lrosebush@bakerlaw.com