Events

Bethesda North Marriott Hotel

Bethesda, MD

June 6 - 8, 2011

2011 PDA/FDA Pharmaceutical Supply Chain Conference & TRI Course
End-to-End Supply Chain Security

Management of the pharmaceutical supply chain is one of the top public health concerns with respect to consumer safety. The globalization of distribution for both drug components and finished products introduces many risks that have yet to be completely resolved by drug product manufacturers and regulators. Unethical parties have shown their ability to infiltrate legitimate supply chains with counterfeited, adulterated and contaminated materials, and in some instances there have been tragic consequences. Naturally, such incidents lead to a loud and swift reaction from the public, health authorities and policy makers. With respect to this issue, FDA Commissioner, Dr. Margaret Hamburg said, “companies that sell contaminated products because of loose supply chain oversight need to face serious penalties … and cannot excuse themselves by blaming their suppliers, blaming FDA or blaming anyone else.” Margaret A. Hamburg, M.D., Commissioner of Food and Drugs - FDA and the American Public: The Safety of Foods and Medical Products in the Global Age, February 4, 2010. Read full remarks.

The PDA/FDA Pharmaceutical Supply Chain Conference & TRI Course is the key industry event for generic and innovator company pharmaceutical manufacturers, suppliers, distributors, transportation providers, and anyone who contributes to the pharmaceutical supply chain to learn about case studies and solutions that can be applied to further secure the supply chain. Also at the conference attendees will be able to network with regulatory and industry thought leaders on this subject.

Confirmed speakers for this year’s meeting include:

Regulator Speakers
• Ilisa Bernstein, PharmD, Director of Pharmacy Affairs, Office of Commissioner, FDA
• Rick Friedman, Director, DMPQ, CDER, FDA
• Connie Jung, PharmD, Pharmacologist, CDER, FDA
• Steven M. Wolfgang, PhD, Team Leader for the Data Analysis Team, CDER, FDA
• And more!

Industry Speakers
• Matthew Anderson, Director, Global Supplier Quality Corporate Compliance, Baxter Healthcare
• Philippe Andre, Auditor and Managing Director, Qualiau Pharmaceutical Auditing Company, Ltd.
• Eric Berg, Director, Supplier Quality, Amgen, Inc.
• Janice Berger, Senior Director, Quality Assurance, AstraZeneca, Inc.
• Jared Byrne, Senior Manager, Supplier Quality Management, Amgen, Inc.
• Lucy Cabral, Director, Quality Assurance, Genentech, Inc.
• Dale Carter, Global Quality Director, Engineered Materials, J.M. Huber
• Brad Elrod, Director, Conveyance Security, Pfizer, Inc.
• Patrick Ford, Senior Director, Global Security, Pfizer, Inc.
• Ashley Goldberg, Senior Manager, Supply Chain Quality, Baxter Healthcare Corporation
• Barrett Hightower, Corporate Compliance Manager, Supply Chain Solutions, BSI
• John Hollenbach, President and Chief Executive Officer, Doe & Ingalls, LLC.
• Brian Johnson, Senior Director, Supply Chain Security, Pfizer, Inc.
• Karl Kussow, Manager, Quality and Validation, FedEx Custom Critical
• Rod MacLea, Director, Supply Chain, Amgen, Inc.
• Gerry Migliaccio, Senior Vice President. Network Performance, Pfizer Global Manufacturing, Pfizer, Inc.
• Karen Moody, President, National Coalition of Pharmaceutical Distributors
• Dwight Mutchler, Vice President, Strategic & Supplier Development, Mutchler, Inc.
• Amy Mutere, Associate Director, Supplier & Distribution, Genentech, Inc.
• Douglas Rich, Executive Director, Commercial Quality, Boehringer Ingelheim
• Londa Ritchey, Director, Supplier Qualification, Pfizer, Inc.
• Edwin Rivera-Martinez, Technical Vice President, Strategic Compliance Service Team, PAREXEL International Corporation
• Susan Schniepp, Vice President of Quality, OSO BioPharmaceuticals Manufacturing
• David Schoneker, Director, Global RA, Colorcon and IPEC–Americas past Chairman
• Irwin Silverstein, PhD, Vice President and COO, IPEA
• Janeen Skutnik-Wilkinson, Director, Quality and Regulatory Policy, Pfizer, Inc.
• Yvonne M. Stewart, PhD, Head of External Advocacy, Global Manufacturing, GlaxoSmithKline
• Neil J. Wilkinson, Partner, David Begg Associates
• Joseph Woodward, Global Director, Logistics & Planning, Avantor Performance Materials
• Martin G. VanTrieste, Senior Vice President, Quality, Amgen, Inc

Learn More
Register – Seats are still available!

P.S. Immediately following the conference, the PDA Training and Research Institute (PDA TRI) will be hosting a stand-alone training course on Developing a Robust Supplier Management Process on June 8th.