Listen "Tired of Supply Chain Errors? Here’s the Fix: Drug Serialization for DSCSA Compliance"
Episode Synopsis
Drug serialization is at the heart of modern pharmaceutical supply chain security. In this episode Michael Rowe, Senior Director of DSCSA and Serialization Services at TwoLabs, talks about the critical role of drug serialization and DSCSA compliance in safeguarding the pharmaceutical supply chain. Michael explains how unique serial numbers, standardized data, and digital traceability are revolutionizing how drugs are tracked from manufacturer to pharmacy. Discover real-world challenges and innovative solutions that ensure product integrity, reduce counterfeiting, and enhance operational efficiency in the pharma industry. Whether you're involved in manufacturing, distribution, or regulatory affairs, learn how embracing drug serialization and DSCSA compliance can transform your operations.🎙️ Guest: Michael Rowe | Senior Director of DSCSA and Serialization Services at TwoLabs🔗 Connect with Michael Rowe: LinkedIn📲 Learn more about TwoLabs More information on FDA and DSCSA📌 Chapters:00:00 Introduction to DSCSA and Its Importance03:07 Understanding the Drug Supply Chain Security Act05:54 The Role of Serialization in Drug Traceability09:04 Impact of DSCSA on Different Stakeholders11:54 Challenges in Compliance and Operational Changes15:01 The Role of Technology in DSCSA Compliance20:21 Blockchain Challenges and Opportunities22:47 AI in Exception Handling27:38 Client Approaches: From Strategy to Implementation32:12 Real-World Compliance Success Stories35:53 Consequences of Non-Compliance38:29 Resources for DSCSA ComplianceSubscribe for more insights on Life Sciences!For transcripts, check out the podcast website - www.lifesciencespod.com
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