Failure Mode and Effects Analysis (FMEA) is a structured process for identifying potential risks and defects of a product or process. This can be used during the development phase, but also during any update or evaluation.
In the quality assurance of sterile production in the pharmaceutical industry, one is forced to analyze every risk area/process. Precisely because of the new EU-GMP Annex 1 of 2022, QA specialists are forced to evaluate more processes according to contamination risk. Through the FMEA, the risks can be defined very quickly and a measure can be determined as required.
In order to be able to convey FMEA quickly and professionally, the skin characteristics in this book have been placed on practical topics and examples.
The book is excellently suited for all those who want to carry out an FMEA quickly and professionally without much prior knowledge.
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Your Parviz Bayegi
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