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FDAnews announces Fourth Annual Supplier Quality Congress

FALLS CHURCH, Va., July 12, 2012 /PRNewswire-iReach/ -- Fourth Annual Supplier Quality Congress


Assuring the Integrity of Drug and Device Raw Materials and Supply Chains

**Presented by FDAnews**

July 31 – Aug. 2, 2012 – Bethesda, MD

Do these questions sound familiar?

  •     "We deal with a lot of companies with satellite plants. Should we have one global quality agreement with the headquarters or one for each facility?"
  •     "Our quality requirements are stated on the back of the purchase orders as standard boilerplate. Is that an adequate quality agreement?"
  •     "I'm being told to accept materials that were shipped prior to a quality agreement being in place? Is this OK?"
  •     "MHRA plans to inspect one of our API suppliers. In addition to the quality system, they also want to review product specific compliance? How should we prepare for that?"
  •     "My suppliers are small. How can I expect them to meet quality requirements?"

At FDAnews we hear questions like this every day from drug- and devicemakers. And the questions are only going to get more complicated; Congress just gave the FDA expanded authority under GMPs to police supplier quality agreements.  What will that mean? What are the answers to all these questions?

There's one place the industry has turned for years for answers: The Supplier Quality Management Congress. Pack up your toughest questions, and join us for this year's conference, July 31 – Aug. 2, 2012, in Bethesda, MD.

It's a day and a half of intensive learning, a crash course in supply chain management and monitoring. Here's just a taste of what you'll discover:

  • Update on supply chain regulation signed by President Obama
  • Best practices for managing risk in the supply chain
  • Import holds and the impact of the FDA's PREDICT system
  • Qualification techniques for international suppliers
  • How to apply lean principles to supplier assessment criteria

Your faculty is an all-star cast of industry executives, members of the bar, consultants and invited FDA officials, including:

  • Melissa Torres, Biomedical Engineer, Office of Compliance, CDRH, FDA
  • Steve Niedelman, Lead Quality Systems and Compliance Consultant, FDA & Life Sciences Practice, King & Spalding
  • Sara Dyson, Assistant Vice President, Medmarc Insurance Group
  • Jonathan Lee, President, Medical Device Consulting Solutions International
  • Stephen Amato, Managing Director, tJun 17 Life Sciences

Conference chairman John Avellanet of Cerulean Associates LLC will be on hand to keep matters on track and moving forward.

Live on-line viewing of the entire 4th Annual Supplier Quality Management Congress

Can't make it to the 4th Annual Supplier Quality Management Congress? Attend the live sessions from your computer. Participate in the live conference from your home or office. Watch the live-streaming video of the presenter and view the presentation materials in real time. Ask questions of the presenters and download handout materials. By registering you will also receive six months' access to archived session recordings after the conference ends. Registration is quick, and accessing the live sessions is as simple as clicking your mouse.


Fourth Annual Supplier Quality Congress
Assuring the Integrity of Drug and Device Raw Materials and Supply Chains
**Presented by FDAnews**
July 31 – Aug. 2, 2012 – Bethesda, MD


Early Bird Price: $1,797 per attendee (through July 17, 2012)
Regular Price: $1,997 per attendee (July 18 – Aug. 2, 2012)

2 Easy Ways to Register

By phone: 888-838-5578 or 703-538-7600

Media Contact: Michelle Butler FDAnews, 703-538-7665,

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