Real-World Serialization in Life Sciences — 2018 - Webinar Recording/Transcript

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Real-World Serialization in Life Sciences — 2018: Track & Trace at a Global Crossroads

The FDA is now regulating serialization under the Drug Supply Chain Security Act (DSCSA). And the FDA is not alone: Regulators worldwide, from Brazil and Argentina to South Korea and Saudi Arabia, are adding scrutiny of their own.

No drugmaker wants to risk a manufacturing slowdown due to overlooked milestones. And with regulation spreading globally, those milestones may be easy to overlook.

To keep you abreast of this fast-changing global regulatory situation, FDAnews has reached out consultant Bill Fletcher. His clients cope with the FDA as well as regulators in China, the EU, Turkey, Argentina, India, South Korea, Saudi Arabia, Brazil and elsewhere.

During a 90-minute presentation, you’ll discover emerging trends in serializing drug products and the systems that track and trace Rx drugs through the supply chain … emerging requirements that go beyond the terms of the Drug Supply Chain Security Act (DSCSA) … specific developments in Brazil and China, two of the fastest-growing emerging markets … new international laws … and much more! By the end, you’ll be prepared to: 

  • Comply with new global traceability requirements
  • Manage child-to-parent aggregation, a particularly frustrating aspect of serialization
  • Skirt pitfalls in track-and-trace, based on experience with some 30 implementations of traceability
  • Move beyond simple DSCA compliance to underlying complexities
  • Deploy state-of-the-art traceability based on cutting-edge third party logistics
  • Implement EPCIS (Electronic Product Code Information Services) and other key standards

If you sell drugs into global markets — and these days, who doesn’t? — this presentation can save you from unanticipated regulatory woes.

Drugmakers, contracted packaging organizations (CPO), contract manufacturing organizations (CMO), third party logistics (3PL) and drug wholesalers/distributors all will benefit from this presentation. Specific job titles include executives in —

  • Packaging
  • Regulatory affairs
  • Warehouse management
  • Shipping management
  • Trade operations
  • Validation
  • Enterprise resource planning (ERP)
  • Security

William (Bill) Fletcher, Managing Partner, Pharma Logic Solutions LLC. With a background spanning 34+ years in pharmaceutical, enterprise software and healthcare systems, Mr. Fletcher’s consultancy focuses on helping clients cope with pharmaceutical serialization and tracking regulations around the world – the U.S. Federal Drug Quality and Security Act of 2013 (DQSA), China, EU, Turkey, Argentina, India, South Korea, Saudi Arabia, Brazil and others. Services for clients also include e-Pedigree strategy, project roadmaps, user and functional requirements, vendor selection, pilot planning and tests, validation, risk or REMS assessment and project planning.