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Pharma’s Evolving Quality Systems: Views from ASQ’s National Director, Donald C. Singer

By Agnes Shanley, Editor in Chief – How long have you been a Baldrige examiner? What kind of background is required for that? – I’ve been in the program for the past two years and have applied again for this year, because you have to apply each year to become an examiner. From what I understand, and I’m not sure about the exact selection criteria, but they require a lot of experience within the quality field — in some cases, experience that’s focused within a particular industry, but also general quality expertise. It took me quite a while, because I’d worked in a number of different industries, to be able to feel comfortable saying that I was very familiar with quality in pharma. I also have a quality background in industries that are somewhat similar to pharma, such as food and cosmetics. – Will a drug company ever win the Baldrige award? Is a change in mindset
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Topics of Interest

By Agnes Shanley, Editor in Chief – How long have you been a Baldrige examiner? What kind of background is required for that? – I’ve been in the program for the past two years and...

By Agnes Shanley, Editor in Chief – We’ve seen recent dramatic cases involving sterility assurance, where internal pharma quality systems failed. What is needed, what are companies...

By Agnes Shanley, Editor in Chief – Does pharma need to bridge its lab and plant floor cultures? – We need to move the lab space to the next level, and that’s where we have an...

By Agnes Shanley, Editor in Chief – Are FDA’s inspectors up to speed with what Agency leaders have been advocating? Do they “get” S88? – There’s a learning curve...

By Ed Silverman and Agnes Shanley There’s a reason Hank McKinnell lost 40 percent of his stock value. I think pharma is needed and is important. My experience is there’s tons of very good...