FDAnews announces Biopharmaceutical Good Distribution Practices Summit

FALLS CHURCH, Va., Feb. 26, 2013 /PRNewswire-iReach/ -- Good Distribution Practices Summit
**Presented by FDAnews**
March 18-20, 2013 – Bethesda, MD

www.fdanews.com/GoodDistributionPractices 

For two days in March the industry's most experienced experts in biopharmaceutical good distribution practices (GDP) will share best practices, war stories and predictions.  The soon-to-be released EU GDP guidelines will have everyone talking.  Now's the time to clear your calendar and register for this important event.

(Photo: http://photos.prnewswire.com/prnh/20130226/CG65938)

As a bonus, FDA officials from CDER and CBER have been invited to share the agency's expectations regarding compliance, enforcement and stability management.

Some must-attend sessions include:

• Developing a Controlled-Environment Logistics Validation Master Plan
• 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
• 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

The truth is, GDP planning, execution and compliance is full of headaches and complications — if you're not prepared.  But for three days in March, you can network with colleagues on best practice solutions to take back to your operations.

Register Today

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 around the world to help you face — and solve — the challenges you encounter day to day. Check this list for names you may know:

• Michele 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, Merck (invited)
• Tim Valko , Executive Director, Operations Risk Management, Amgen (invited)

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 ... and, more important, discover what you need to know for greater company and career success.

CONFERENCE DETAILS

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

TUITION:
Early Bird (Must register by March 5, 2013): $1,697 per attendee 
Regular Tuition (March 6 – March 20, 2013): $1,997 per attendee

4 Easy Ways to Register
Online: www.fdanews.com/GoodDistributionPractices
By phone: 888-838-5578 or 703-538-7600
Fax:         703-538-7676
Mail to:     FDAnews
               300 N Washington St 
               Ste 200
               Falls Church VA USA 22046-3431

Media Contact:

Jeff Grizzel , FDAnews, 703-538-7668, jgrizzel@fdanews.com

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