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Featured Articles

July - September 2012

Ruth Dubinsky

When Good Teams Go Wrong

by Ruth Dubinsky
MS, President, Clarity Consulting

How's your team doing? Are you hitting your targets without leaving "dead bodies" in the wake? Do you sense trust, commitment, and accountability from your fellow team members?

If the answer is yes, fantastic—you're in an elite club! But if your team is like many others, sometimes (or more often than not) you feel "dysfunctional." Not quite working on all cylinders... not cooperating or communicating well... not making decisions that stick. Dealing with power struggles that exhaust and frustrate everyone. Running on empty.

So, what makes good teams go wrong? It's rarely a lack of technical skills. Many good teams have all the experience and technical knowhow they need. But they tend to miss or ignore signals that suggest the rudimentary, essential elements of teamwork are absent on their team—and they are unable or unwilling to recognize how this dysfunction sabotages their efforts.

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Cindy Fazzi

FDA Says Part 11 Guidance Remains Status Quo

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

Time and again, rumors surface about the possible update of the 2003 guidance on the scope and application of 21 CFR Part 11. The never-ending speculation attests to the enduring interest in Part 11, not to mention the continued scrutiny of the regulation.

Asked to comment on the status of the 2003 guidance, Erica Jefferson, an FDA press officer, told GxP Lifeline: "There are currently no plans to update the guidance. We are still performing inspections per the 2003 guidance."

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Patricia Santos-Serrao

Quality and Risk Management in Clinical Studies

by Patricia Santos-Serrao
Senior Product Manager, Life Sciences, MasterControl, Inc.

With all that goes into a clinical trial, from documentation and procedures, to a variety of study support staff, managing risk may often be overlooked or merely addressed in a reactive way. However, in order to increase success in clinical trials, an organization must have an efficient risk management plan and be proactive and not simply reactive. In order to obtain a complete understanding of risk in a clinical trial, a risk assessment must be taken from various perspectives. Also, risk management is more than just assessing the risk; it should include contingency plans for rectifying and preventing risk in order to minimize risk.

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Did You Know?

CAP 2012 - The Pathologists' Meeting™
September 9-12, 2012, Manchester Grand Hyatt, San Diego, CA

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Did you know that July is National Cord Blood Awareness Month?
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