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FDAnews announces Biopharmaceutical Good Distribution Practices Summit
Date:1/24/2013

harma (invited)
  • Mark Seitz , Global Logistics Advisor/Director, Eli Lilly(invited)
  • Sally Wong , Stability Manager, Eli Lilly (invited)
  • Tim Valko , Executive Director, Operations Risk Management, Amgen (invited)
  • Register Today

    Combining a mix of presentations and panel discussions — featuring regulators and industry experts — this Summit has something for everyone.  Each presenter and panelist will be providing a few "take-away" solutions.  After three days, you'll leave with 50 solutions, tips and tricks to take back to your company.  Anticipated Summit sessions include:

    • Developing a Controlled-Environment Logistics Validation Master Plan
    • Cubist Pharmaceutical Case Study:  Managing a Virtual Supply Chain
    • FDA's Perspective on GDP:  Harness and Harmonize Your Operations and Quality Teams
    • Without True Distribution Validation Integrity, You're in for a World of (Global) Hurt
    • Panel Discussion:  Strengthening the Distribution Chain — How to Protect Your Product from Crooked Employees, Pirates, Warehouse Warriors and Other Miscreants
    • Applying Proven Risk Management Controls to Stability Testing to Support Distribution of New Drug Products
    • Maybe the World Isn't Coming to an End, But It Sure Seems Like That on Some Days — Contingency Planning Best Practices for Biopharmaceutical GDPs
    • Panel Discussion: Good Distribution Practice Quality Agreements — Can't We Just All Get Along? Understanding Where Industry Has Consensus and Differences
    • Packaging As the First Line of Defense Against Counterfeiting

    Register now. You'll e
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