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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
    . This categorization made it easier to break the list down into smaller sections for the FMEA. Failure Mode
  • Medical Device Link .
    GUIDE TO OUTSOURCING: RISK ANALYSIS A growing number of medical device manufacturers have adapted tools used by automotive and other manufacturers. This is particularly true for risk plans known as failure mode and effects analysis (FMEA) and their operational counterparts, control plans
  • Precsion Metal Stamping Quality -- Acronyms You've Got to Know.
    . There's APQP, DFM, FMEA, GR&R, IQ/OQ/PQ, and more.
  • 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
  • Process Excellence in the Manufacturing Value Chain
    aims, systematically, to eliminate variation by Defining, Measuring, Analyzing, Implementing and Controlling processes, abbreviated as DMAIC. Within Six Sigma projects, a variety of tools are employed. These include: Failure Mode and Effects Analysis (FMEA) - a systematic group of activities
  • From the Editor: Deconstructing Murphy
    pharmaceutical industry decision today, more non-engineers in the industry are also learning to take a "worst case " view, and use engineering tools to manage risks, on the plant floor and in the lab. One of the most powerful tools to help in this daunting task is Failure Modes and Effects Analysis (FMEA
  • QbD Takes Biopharma by Storm
    By Angelo De Palma, Ph.D., Contributing Editor FMEA is utilized at the lowest level, not only by top-down designers off site by process engineers on the plant floor. One of the first steps of FMEA is defining and detailing a process map: What steps in the process or formulation lead to the finished

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