• Medical Device, Pharmaceutical & Biotech
• by Joe.Goodman
• Sep 1, 2010
• No Comments

Bethesda, MD was abuzz this past week as the FDANews.com hosted the 2nd Annual Supplier Quality Management Congress held at the Bethesda North Marriott Hotel & Conference Center. At the event, supplier quality personnel from both pharmaceutical and medical device organizations came together to exchange ideas and information about the ever changing supply chain.

Day one started with a keynote address from two well respected FDA representatives, Dr. Carmelo Rosa who shared some interesting statistics about warning letters for the pharmaceutical space. He noted that in the pharmaceutical industry there were 16 warning letters issued in 2009, while there are 19 for this year already! The second speaker was the ever popular Kim Trautman discussing SQM trends and the six phases of supplier control, which include: planning, selection, evaluation, controls, delivery measurement, monitoring and feedback (including CAPA).

The track sessions were split between pharmaceutical and medical device. Most of my time was spent in the medical device track and the crowd participation was plentiful, which tells me there is a lot of passion around getting these SQM issues fixed at many companies big and small.

The final day wrapped up with a question and answer session with Sparta Systems very own Industry Principle, Tim Mohn. The attendees spoke quite a bit about their thoughts and lessons learned from the two day conference, and their questions were primarily focused on implementation of the newly learned techniques and programs for their supplier quality management system.

With reports of supply chain quality failures making front-page headlines daily, incidents have the potential to be disastrous for global manufacturing organizations. More than ever companies need to be proactively addressing their supplier quality issues with tools and processes that prevent incidents from arising before they have a chance to do significant damage to businesses or consumers.