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 Importance
03:07 Understanding the Drug Supply Chain Security Act
05:54 The Role of Serialization in Drug Traceability
09:04 Impact of DSCSA on Different Stakeholders
11:54 Challenges in Compliance and Operational Changes
15:01 The Role of Technology in DSCSA Compliance
20:21 Blockchain Challenges and Opportunities
22:47 AI in Exception Handling
27:38 Client Approaches: From Strategy to Implementation
32:12 Real-World Compliance Success Stories
35:53 Consequences of Non-Compliance
38:29 Resources for DSCSA Compliance
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For transcripts, check out the podcast website - www.lifesciencespod.com
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