A fishbone diagram, also known as the Ishikawa digram after its inventor, is a visual representation of all causes that result in a particular outcome. The final outcome is represented on the far ...

One new and different item laid out in the Evaluation of Corporate Compliance Program (Evaluation), supplementing the Ten Hallmarks of an Effective Compliance Program from the 2012 FCPA Guidance, was ...

At one stage or another, all projects are subject to risks and being able to isolate problems can be tricky. Knowing how to conduct a root cause analysis can help your teams get to the source of each ...

Getting to the root of the cause can prevent future problems, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates. Q: I am ...