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Paper on risk-based approach to quality management

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Reference no: EM132576212

Please use the link attached to answer the question.

Please read FDA's risk-based approach guidance and EMA's reflection paper on risk-based approach to quality management. Both are also posted within the BlackBoard system and can be found on FDA and EMA's website. Please answer the following questions:

  • How are these documents similar? How different? Provide a brief summary of each that allows for this comparison.
  • After reviewing these guidance documents do you believe taking a risk-based approach involves ‘taking short-cuts'? Why or why not?
  • Do you believe it is possible to achieve a higher level of quality by taking a targeted approach to data review as opposed to implementing 100% review strategy? Why or why not?

Please provide a two page paper addressing the above-referenced questions

Reference no: EM132576212

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