Serializing Your Global Supply Chain - Webinar CD/Transcript

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Serializing Your Global Supply Chain: Myths and Misconceptions about Track and Trace

Track and trace expert Evren Ozkaya, tackles the numerous issues and misconceptions surrounding new track and trace requirements.

The requirements for track-and-trace are relatively new, and new aspects of them are continually coming into force. As of May 1, 2015, the Drug Supply Chain Security Act (DSCSA) is fully enforced for manufacturers, wholesalers and repackagers, with many additional requirements (such as for pharmacies) going into effect at a later date.

Currently, manufacturers must incorporate product transaction data into a single document that is available, either electronically or on paper, each time ownership is transferred. This must include transaction data listing, lot-level information, a complete transaction history and a transaction statement, and must be maintained for six years afterwards.

By November 2017, that information must be available electronically, and the product identifier must be affixed or imprinted on the label at the product and case level. This lot-level serialization will present a major challenge for drug manufacturers, requiring extensive work at every point of their supply chain.

This extends to the global level: serialization requirements are in various stages of development in the EU and in its member nations, as well as in Turkey, India, China, Brazil, Argentina and Korea. The most recent change occurred in Brazil, where all pharmaceuticals must be serialized and tracked by Dec. 10, 2016.

If you're concerned about the new requirements, and who isn't? — you won't want to miss out on this opportunity to get detailed input from this acknowledged expert. In just 90 minutes, you will learn:

  • Deadlines for serialization and how your timeline must reflect them
  • Old technology vs. new: How your supply chain needs to transform for compliance
  • The biggest myths and misconceptions about track-and-trace
  • Thinking globally: Is the U.S. lagging behind the rest of the world?
  • Auditors
  • Compliance officers
  • Consultants/service providers
  • Data management and statistics personnel
  • Executive management
  • General/corporate counsel
  • Investigators
  • Managers
  • Manufacturing directors and supervisors
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Strategic planning and business development staff

Evren Ozkaya, Ph.D., Founder and CEO at Supply Chain Wizard, LLC
Mr. Ozkaya is an operations & strategy executive and entrepreneur with 11 years of deep experience in research, design and implementation of supply chain strategies and transformation initiatives across seven industries, primarily focusing on the pharmaceutical industry, with a track record of high impact projects, while building and coaching talented teams for sustainable results. Prior to founding Supply Chain Wizard LLC, he worked with Sandoz as Director of their global track-and-trace program and did strategic planning for their North American supply chain. Other past employers include the United Nations World Food Program, Coca Cola, and Intel. His specialties include track & trace, serialization, strategic planning, project management, sales & operations planning, operational risk management, inventory optimization, forecasting and demand management, production planning and distribution strategies and procurement of transportation services.