1 FDA 21 CFR 820 Quality Systems Regulationbr br 2 Project Program Managementbr br 3 Corrective Action Preventive Action CAPA, Nonconformances NCRsbr br 4 New Product Developmentbr br 5 Design Verification and Validationbr br 6 Process Validation Installation Qualification IQ, Operations Qualification OQ and Process Qualification PQbr br 7 Change Control Processbr br 8 Risk Control, Design Failure More and Effect Analysis DFMEA and Process Failure More and Effect Analysis PFMEAbr br 9 Root Cause Analysisbr br 10 GD T Tolerance Stackupbr br Any suitable combination of education, training and experience is acceptable. Special skills can be gained through academic coursework, scholastic achievement, or professional experience.
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