Tarek Elneil

12 Abonné

Sr. Quality Engineer with over 14 years of experience as a change agent for Continuous Quality Improvement in the biotech, pharmaceutical, medical device, and dietary supplement industry; with an extensive experience in problem solving and root cause analysis. Improved the quality systems and reduced the closure of nonconformance and deviation cycle time. Trained employees on problem solving and root cause analysis, which reduced 75% of the nonconformance average cycle time. Managed process improvement projects, and led CAPA cross-functional teams to investigate quality failures utilizing the Six Sigma tools. As a Certified Manager of Quality and Organizational Excellence, I was the gue...

report investigations manufacturing failure nonconformance category analysis root cause frequency hazard risk analysis risk management fda capa determination risk detectability severity capa capa decision hazard analysis training new hire on the job training quality human error sop standard operating procedure

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Tarek Elneil

Root cause classification

CAPA Decision

Risk Management for CAPA Decision 1

Risk Assessment for CAPA Determoination (decision)

Human errors

FDA and Medical Device Reporting

Process variation and continuous improvements

Rca Case Study R6

Continuous Improvement And Rca Rg Rev 2