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FDAnews announces Biopharmaceutical Good Distribution Practices Summit

FALLS CHURCH, Va., Jan. 24, 2013 /PRNewswire-iReach/ -- Good Distribution Practices Summit
**Presented by  FDAnews**
March 18-20, 2013 – Bethesda, MD


FDA-Regulated Manufacturers — If one syringe goes missing in your distribution chain, you could be facing a total recall.  Or, if your product exceeds its maximum allowed temperature by a fraction of one degree, the whole lot might have to be destroyed.

Welcome to the emerging — and risk filled — world of good distribution practice (GDP) compliance.

For example, a product may be manufactured at a foreign facility, shipped by air or ship to the US, transferred through an airport or port, loaded onto a truck, moved between 2-3 distributors all before reaching the pharmacy or patient.  At any of those points, if you can't convince regulators you have maintained security and stability controls, you could be looking at a Form 483 or other warning.

Inspectors are requiring manufacturers to prove they have adequate risk management controls in place AND provide detailed records and test results that assure temperature stability of past shipments.

The truth is, you're in for more headaches and complications.  But there's help close at hand.  FDAnews welcomes you to Washington, D.C., to learn and share with your colleagues best practices to maintain GDP compliance.

Come to Washington Monday-Wednesday, March 18-20, 2013, for the Biopharmaceutical Good Distribution Practices Summit.

It's three days and two nights of face-to-face interchange with regulators, GDP pioneers, policymakers, risk management experts and consultants — and, not least, your fellow executives at FDA-regulated manufacturing enterprises coast to coast and around the world.

The Summit is the opportunity you've been looking for. We've invited top FDA officials with supply chain and stability oversight. Just look who's on the invitation list:

  • Steven Lynn , Acting Director, Office of Manufacturing and Product Quality, CDER, FDA
  • Thomas Christl , Acting Director, Office of Drug Security, Integrity and Recalls, CDER, FDA

But Washington is only half the story. We've also invited an array of knowledgeable GDP execs from leading drug and biotech firms to help you face — and solve — the challenges you encounter day to day. Check this list for names you may know:

  • Michelle Johnson , Supply Chain Advisor, Cubist Pharmaceuticals  (Co-Chair)
  • Gary Hutchinson , President, Modality Solutions LLC, formerly Director of Global Transportation, Amgen (Co-Chair)
  • Barbara Falco , President, Barbara Falco Pharma Consulting, former QA Director at Abbott Laboratories
  • Ash Patel, Associate Director, Product Security & Brand Integrity, Biogen Idec
  • Rebecca Gentile , Senior Specialist, Quality, Global Vaccine & Biological Stability, Merck
  • Andrew Mills , CEO, Intelsius
  • Maryann Gribbin , Director Quality Assurance, Johnson & Johnson, formerly Consumer Safety Officer, New Jersey District, FDA (invited)
  • Charles Forsaith , Director, Supply Chain Security, Purdue Pharma (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 enjoy early-bird savings of up to $300 until Feb. 8, 2013 ... and, more important, discover what you need to know for greater company and career success.

Good Distribution Practices Summit
**Presented by  FDAnews**
March 18-20, 2013 – Bethesda, MD

Early Bird (Must register by Feb. 8, 2013): $1,697 per attendee 
Regular Tuition (Feb. 9 – March 20, 2013): $1,997 per attendee

4 Easy Ways to Register
By phone: 888-838-5578 or 703-538-7600
Fax:    703-538-7676
Mail to: FDAnews
                  300 N Washington St
                  Ste 200
                  Fall Church VA USA 22046-3431

Media Contact: Jeff Grizzel FDAnews, 703-538-7668,

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