#116 – WHAT QUALITY REALLY MEANS? – LANE HIRNING

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Posted on November 21, 2015 by greg

A friend of mine recently asked me to review his PowerPoint presentation for an upcoming investor conference, which I was happy to do. The first thing that struck me was his choice of fonts—different types and different colors. Second was the slide templates creating an inconsistent layout. It seemed like a trivial thing to point out, but I had to ask him: What kind of a first impression are you going to make with this presentation? Continue reading →

#114 – THREE THINGS I’VE LEARNED ABOUT QUALITY PROFESSIONALS – JOHN BECKSTRAND

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Posted on November 8, 2015 by greg

Over the past 15 years, as the leader of an organization dedicated to improving the success of the quality profession, I have met hundreds of people throughout the world who have a unique mission: build greater quality into the things we use every day. Continue reading →

#111 – FDA REQUESTS PUBLIC INPUT ON QUALITY METRICS GUIDANCE – OLIVER WOLF

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Posted on October 16, 2015 by greg

In line with the general shift towards risk-driven approaches in the quality management world, FDA is now taking steps towards applying those same principles to its own auditing schedule. At the end of July, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) released the draft guidance “Request for Quality Metrics” and is now seeking public input by September 28, 2015 on a number of key points. Continue reading →

#108 – CAPA SHOULD NOT BE A DREADED 4 LETTER WORD – CINDY FAZZI

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Posted on September 27, 2015 by greg

In a regulated environment, CAPA is a requirement for addressing and mitigating deviations and nonconformances. A quick review of FDA warning letters indicates it’s a dreaded four-letter word for many companies cited for violations. Continue reading →

#96 – RISK MANAGEMENT IN CLINICAL RESEARCH: PROCESS AND APPLICATION – EMILY HAGLUND

Posted on June 21, 2015 by greg

Recently, two key pieces of guidance were released from Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding risk based approaches to clinical research. These documents include FDA’s “Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” and EMA’s “Reflection paper on risk based quality management in clinical trials”. Continue reading →

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Category Archives: Pharma@Risk™

#116 – WHAT QUALITY REALLY MEANS? – LANE HIRNING

Featured

#114 – THREE THINGS I’VE LEARNED ABOUT QUALITY PROFESSIONALS – JOHN BECKSTRAND

Featured

#111 – FDA REQUESTS PUBLIC INPUT ON QUALITY METRICS GUIDANCE – OLIVER WOLF

Featured

#108 – CAPA SHOULD NOT BE A DREADED 4 LETTER WORD – CINDY FAZZI

Featured

#96 – RISK MANAGEMENT IN CLINICAL RESEARCH: PROCESS AND APPLICATION – EMILY HAGLUND