GxP Lifeline December 2008 - Your Resource for Life Science Intelligence

December 2008

Video:

Improving Quality in Your Work Environment

Feature Article:

Making the Move to Collaborative Environments

For Pharmaceuticals and Biotechnology:

From Poison Squad to Industry Regulator- A Historical Perspective of the FDA


For Medical Device:

Managing Outsourcing Operations Reduces Risk

For Blood & Biologics:

Conferees Seek Paths to Improving Blood Center IT Systems

News for Life Science Professionals

New Firebird System Makes Clinical Trial Registration Easier

Did You Know?

Did you know that most of the life science companies analyzed in a recent report by the AberdeenGroup could not be categorized as Best-in-Class manufacturers?


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Making the Move to Collaborative Environments

In today's fast-paced business environment, collaborating is the name of the game. To complete a task, working with other employees or suppliers is often required---and challenging. Kate Merlino of nSight shares her experience in working successfully with collaborative environments.

What is a collaborative work environment? Almost all work has collaborative elements: we work with co-workers, managers, and subordinates in teams, committees, and departments. We use many environments and tools to share information and ideas. While working together is not a new concept, technological advances and shifts in workplace culture have changed the way we work.


For Pharmaceuticals and Biotechnology: From Poison Squad to Industry Regulator- A Historical Perspective of the FDA

America's Founding Fathers didn't invent the FDA. The focus on defending the public's health was of little concern until 1820. How did the life science industry go from no regulation to federal oversight in nearly 200 years?


For Medical Device: Managing Outsourcing Operations Reduces Risk

Outsourcing operations is a popular tool for reducing the costs of manufacturing a product. Outsourcing is not without its problems when appropriate oversight is lacking. What is the best way to reduce risk when outsourcing manufacturing operations?


For Blood & Biologics: Conferees Seek Paths to Improving Blood Center IT Systems

Blood community professionals and vendors met with officials from the Food and Drug Administration in a first-of-its-kind conference examining the impact of federal regulations on the development of donor and transfusion information technology (IT) systems. The conference, which was originally budgeted for about 60 attendees, drew 170 registrants and a great deal of interest in the impact of federal regulation on the development of donor and transfusion information technology (IT) systems.


News for Life Science Professionals: New Firebird System Makes Clinical Trial Registration Easier

According to a recent FDANews article, clinical trial investigators may find that registration for trial investigations will become more rapid, secure and efficient via the cooperation of the National Cancer Institute (NCI), the FDA and CRIX. The new system for registration is referred to as the Federal Investigator Registry of Biomedical Information Research Data (Firebird).


Did You Know?

Did you know that most of the life science companies analyzed in a recent report by the AberdeenGroup could not be categorized as Best-in-Class manufacturers?



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