Pharmaceutical | Biotechnology | Medical Device and In-Vitro Diagnostics
- Developed and implemented a preventative maintenance program
- Developed and documented a Risk Management Plan, and conducted the Hazard Analysis, FMECA, and FTA
- Provided regulatory support for 510k filing
- Developed a strategy for handling combination product FDA requirements late in the development cycle, and wrote compliance documentation
- Established quality systems for device manufacturing
- Implemented corrective actions (CAPA) based upon FDA warning letter citations
- Prepared and implemented QSR training program for combination products
- Developed and executed validation protocols and prepared the reports
- Performed internal audits per QSRs, identified system deficiencies and assisted with corrective actions
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