Biopharmaceutical Good Distribution Practices Summit

$1,997.00
Quantity Discounts
1 - 9999
$1,997.00
1 - 9999
$1,697.00
1 - 9999
$597.00
 
 
 
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
March 18 - 20, 2013
Doubletree Hotel, Bethesda, MD

Register Today

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.

We’ve 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:

  • 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
  • B. Brett Heavner, Partner, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
  • Stephen Healy, European Sales Director, Intelsius
  • Kim Egan, Founder, Saltbox Consulting, formerly Partner, Co-Chair Health Care Sector, Co-Chair,
    Clinical Trials Working Group, DLA Piper LLP

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
  • Developing a Controlled Environment Logistics Validation Master Plan
  • You Are Your Brand, Your Brand Is You — Combating Counterfeiting
  • Industry Update — Why Rx-360's New Initiatives Could Change The Way You Operate
  • 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 Biopharmaceuticals GDPs
  • Cubist Pharmaceutical Case Study: Managing a Virtual Supply Chain
  • Good Distribution Practice Quality Agreements — Can’t We Just All Get Along? Understanding Where Industry Has Consensus and Differences
  • A Regulator Dissects Current Track-and-Trace Strategies
  • Packaging As the First Line of Defense Against Counterfeiting

Register now.

2013 Sponsors:

For 2013 exhibit options and sponsorship packages contact Colette McMullen, Director, Business Development at (703) 538-7642 or cmcmullen@fdanews.com

2013 Venue:

Doubletree Bethesda Hotel
8120 Wisconsin Avenue
Bethesda, MD 20814
Toll free: (800) 560-7753 • Tel: +1 (301) 652-2000
www.doubletreebethesda.com
Room rate: $215 plus 13% tax
Reservation cut-off: Feb. 25, 2013

Register for 2013:

 
Regular Fee
Complete Summit
$1,997
Conference Only
$1,697
Preconference Workshop
$597

Send Your Team for Maximum Benefit
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Significant tuition discounts are available for teams of two or
more from the same company. You must register at the same time and
provide a single payment to take advantage of the discount. Register below
by clicking on add to cart and then change your quantity in the shopping cart.
The discount will be calculated automatically.

2-4 attendees – 10%
7-9 attendees – 20%
5-6 attendees – 15%
10+ attendees – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600
globally with any questions.

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Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.

Cancellations and Substitutions

Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.