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How do you validate a novel manufacturing process if there is no applicable guidance?
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If your company has a novel manufacturing process, then you will need to understand how to create validation protocols for each phase of the validation from scratch. Medical Device Academy will provide process validation training on YouTube as a live streaming video. The training will cover four basic elements of process validation:
➤ Installation qualification (IQ) – installation, calibration, maintenance, and cleaning
➤ Process risk analysis or process failure modes and effects analysis (pFMEA) – hazard identification, risk evaluation, and implementation of risk controls
➤ Operational qualification (OQ) – challenging process parameters, design of experiments (DOE), raw material specifications, process operating procedures, training, and process monitoring
➤ Performance qualification (PQ) – repeatability, reproducibility, lot variability, process capability, and product acceptability
Medical Device Validation Handbook, Edited by Max Sherman 2nd Edition...search using "Validation Handbook" as the terms
➤ Installation qualification (IQ) – installation, calibration, maintenance, and cleaning
➤ Process risk analysis or process failure modes and effects analysis (pFMEA) – hazard identification, risk evaluation, and implementation of risk controls
➤ Operational qualification (OQ) – challenging process parameters, design of experiments (DOE), raw material specifications, process operating procedures, training, and process monitoring
➤ Performance qualification (PQ) – repeatability, reproducibility, lot variability, process capability, and product acceptability
Medical Device Validation Handbook, Edited by Max Sherman 2nd Edition...search using "Validation Handbook" as the terms
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