The Most Important Question to Ask About Your Audit Program
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Don't approach audits with fear of what will be found, but excitement about discoveries for improvement
Credit: Marisa Watts
Tougher Quality Management Enforcement Possible by FDA
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The FDA will have more funding to do its job—including more inspections of life sciences manufacturers
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.
Still Improving (and Dancing) Despite Budget Cuts
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Sean Doering, a 2016 graduate, and Associate Professor Jen Grant discuss Doering’s research conducted in the Student Jobs Program.
Credit: UW-Stout
Signal vs. Noise
The attempt to eliminate noise from an operating system or a business process is an interesting and perhaps worthwhile challenge, until one considers the question: What is the real signal? What is creating the noise?
Key Challenges for Risk Management in Medical Device Development
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Risk management is a full life-cycle activity for medical device development
ISO 9001:2015—Establishing the Context of the Organization
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Context. What the heck is that and how do you apply the term to your organization?
Credit: Takako Tominaga
One of the newest parts of ISO 9001:2015 and related management standards are the concepts of context and interested parties. What do these mean, and how can you apply them to your organization?
When Foreign Firms Are No Longer Welcome
Pulling out of a country is an expensive proposition for a multinational firm, but it is sometimes required for the corporate bottom line. If the host country changes laws or even expropriates a subsidiary, it is often time to leave or divest.