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Quality System Remediation, IVD
Conduct Audit of Quality System and develop Remediation Plan for In-vitro Diagnostic Devices. |
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Provided firm with Audit report, 483 style findings and Corrective Action Plan. Revised and developed Quality System SOPs for CAPA, OOS, Product Complaint Handling, Design Control and Management Controls. Conducted training on QSR, CAPA, Design Control etc. |
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