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  • Washington Letter: FMEA as a Packaging Tool
    as powerful tool. In fact, the FDA even uses FMEA itself, to help weed out confusing drug names once a new drug application (NDA) has been submitted. But neither the FDA nor the drug industry use FMEA to assure the development of clear, consistent drug labeling and packaging. According to the IOM
  • FMEA: A Risk-Based Approach to Sterility Assurance
    By Craig Alexander, P.E., Monsanto Co. This technique is a written brainstorming tool that refers to having six people each write down three responses to a problem in five minutes. Each participant begins with a worksheet divided into five rows of three columns. A question or problem statement
  • Lean Pharma: If Only It Were This Easy
    ldquo;You can 't call it Lean or Six Sigma when someone at a low level in the organization gets interested in 5S, Failure Mode and Effects Analysis (FMEA) and other tools and applies them in a few places. They can try some things in good faith and score some early wins, but without leadership

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