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Featured Articles

June 2012


Emma BarskyLen Grunbaum

Quantifying Quality for GxP Compliance

by Emma Barsky and Len Grunbaum
Regulatory Compliance and Operational Consultants

GxP professionals understand the need for quality and quality systems and we discuss quality with one another on a daily basis. But how do we measure it? How do we quantify our results? Once again we turn to Len Grunbaum and Emma Barsky, regular contributors to GxP Perspectives, for their insight on how to quantify quality for the development manufacturer, and distribution of health products such as drugs, medical devices, and biologics.

In its simplest form, the definition of "quality" is "how good something is." But what exactly does this mean for the life science industry, whose frame of reference is defined by regulations which are often vague and which provide little or no guidance regarding how they should be implemented?

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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

Implementing a New System: Training Reinforcement Critical

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

It all sounds familiar: You attend a training course that you are excited about. You spend two or more days soaking up new information. You take notes diligently. Before you know it, the training is over. You go back to the office. And after a while, it happens: The new knowledge fades.

You're not alone. It is estimated that up to 80 percent of what we learn from training courses are lost within 30 days—unless the knowledge is reinforced. This is true for the CAPA-investigation class that you attended and the software training on the new quality system that your company is implementing.

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Did you know that the FDA has released a global engagement report detailing its activities and strategies for expanding its domestic policy to a global framework? "As our world transforms and becomes increasingly globalized, we must come together in new, unprecedented, even unexpected, ways to build a public health safety net for consumers around the world," said FDA Commissioner Margaret A. Hamburg, M.D.
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