July 2013

For Pharmaceutical Companies

Uncertainty and Risk: Providing Value for Stakeholders

by: Greg Hutchins, Quality + Engineering (Q+E)

In Against the Gods: The Remarkable Story of Risk, the author says the mastery of risk is the foundation of modern life and is what divides modern from ancient times. By consciously or unconsciously calculating probabilities, auditors make intelligent decisions about business processes.

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Creating, Staffing and Managing an Inspection War Room

by: Walt Murray, MasterControl Inc.

When I served in the military there was a term used that is still pretty familiar today: "sound general quarters!" When this order was issued, everyone instinctively stopped what they were doing and manned whatever station was theirs during that time. All commands during general quarters came from the war room behind the bridge of the vessel. When the FDA comes calling, will your war room be ready?

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Human Genome Project Spurred $966 Billion Sciences Boon

by: Drew Armstrong, Bloomberg

The $14.5 billion investment by the U.S. in the Human Genome Project, completed a decade ago, has paid off more than 60-fold in new jobs, drugs and a rapidly expanding genetics industry, an analysis has found.

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