LSIT is pleased to be a part of the Society of Quality Assurance's one-day symposium which will discuss the impact of the USP Chapter <1058> Analytical Instrument Qualification (AIQ) and holistic validation approach to the regulated bioanalytical laboratory. The event will be held at at the Holiday Inn BWI in Baltimore, Maryland on January 25, 2008. In addition, the SQA is offering LSIT members a special discounted rate.

For more information on the rationale behind the symposium and the scheduled speakers, you can download the
Symposium Brochure (PDF), or visit the symposium website.

From the San Diego Union Tribune:

San Diego wireless technology giant Qualcomm is planning to launch a mobile network that would allow people to use their cell phones to manage myriad health issues including diabetes and dieting.

Called LifeComm, the service would offer cell phones that could double as glucose meters to monitor blood sugar levels in diabetics, track aerobic activity in dieters or otherwise function as a medical device.

The new wireless phone service is expected to launch in the second half of next year in the United States.

Read the full article at the San Diego Union Tribune

President George W. Bush and Commerce Secretary Carlos M. Gutierrez recently announced that five organizations, including San Diego's Sharp Healthcare are the recipients of the 2007 Malcolm Baldrige National Quality Award, the nation’s highest Presidential honor for organizational performance excellence. This marked the first time in the history of the Baldrige Award, nonprofit organizations have been selected.

Along with Sharp, the recipients included PRO-TEC Coating Co., Mercy Health System, the City of Coral Springs and the U.S. Army Armament Research, Development and Engineering Center (ARDEC).

For more information, you can read the full press release.

Improvements to the technology infrastructure for researching and developing new biopharmaceuticals would be expected to save the industry hundreds of millions of dollars annually, according to a new economic study sponsored by the National Institute of Standards and Technology (NIST).

Prepared by RTI International for NIST, the study¡¯s authors found that over the last two decades emphasis in new drug development has shifted from small-molecule chemicals to large-molecule proteins and other biopharmaceuticals such as human insulin, gene therapies and specialized antibiotic treatments. The report notes that the biopharmaceutical industry currently spends about $21 billion annually on research and development and has commercialized over 400 products.

Read the full article at Science Daily, or download the NIST Report (pdf).

by Sion Wyn

Over recent years a number of significant initiatives, from both international regulators and industry, have influenced thinking on how validation in the regulated GxP environment might be achieved in the most effective and efficient manner. This has led to focusing validation on those items that affect product quality and public health using a risk- and science-based approach.

There has also been a major move toward the use of products and packaged solutions and away from bespoke developments.

As a result the GAMP Council is planning to revise the GAMP Guide to reflect current regulatory expectations and current industry good practice while maintaining continuity with GAMP 4 principles. The Guide will be focus on the use of products and packaged solutions rather than custom (bespoke) systems.

For more, visit ISPE's GAMP Community News.