QA Talk - A Year of Change

Happy New Year Everyone!

As 2009 opens, we embrace a year of change and it could not have come at a better time. The economy is a state I would never have expected in my life time. Many colleagues are employed and either can not find work or cannot find work in an environment that will make them happy. Most of America's management continue to have the micro-management mentality where they must see you in the "central" office because they can't monitor your comings and goings if you are home based. Other managers are smart enough to know that it can be an enormous savings for both the company and the employee to have home-based workers. It would be great to see more managers move in that direction, which would save on fuel and time loss sitting in traffic.

Many colleagues have gone the independent route. I urge you to stay abreast of industry current standards. Consider taking online courses at http://www.wqats.com/Training.html. They are affordable and readily available.

The FDA offer several podcast for us to better understand their view about cerain industry practices. Check it out at http://www.fda.gov/cder/drug/podcast/Unapproved_Drugs_ReachMD_DrWoo.htm. Also, check out the new guidances, especially the one on handling information obtained from subjects who have withdrawn or was terminated from a clinical study.

The FDA have now partnered with WebMD to help consumers have even more access to vital information. They have announced that there are about 25 weight loss pills that could be harmful to the public. Web MD can now help them get this information out to the public by showcasing it on their website and in their magazine.