Despite advances in automation, pharmaceutical operations continue to involve the human – machine interface. As many internal investigations point out, human error continues to be a major causative factor. The challenge in advancing pharmaceutical operations is to reduce the potential for errors. During the Human Factors and Human Error Reduction Workshop different tools will be presented to be used in conjunction with quality system tools that may allow managing improvements in operations as process re-design may be an outcome of an investigation taking Human Factors under consideration.