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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
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:
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:
For 2013 exhibit options and sponsorship packages contact Colette McMullen, Director, Business Development at (703) 538-7642 or email@example.com
Doubletree Bethesda Hotel
8120 Wisconsin Avenue
Bethesda, MD 20814
Toll free: (800) 560-7753 • Tel: +1 (301) 652-2000
Room rate: $215 plus 13% tax
Reservation cut-off: Feb. 25, 2013
Register for 2013:
Send Your Team for Maximum Benefit
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600
Payment is required by the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.
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.
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