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RA/QA/QC ResponsibilitiesRA/QA/QC Responsibilities
Developing SOPs. Implementing the SOPs. Monitoring. Auditing. GCP training. Filing an adverse event report. Filing premarket clearance applications. Conducting internal audits. Determining the root cause of a problem that involves compliance with FDA requirements. Overseeing the corrective action for that problem. Overseeing preventive action for that problem.
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Handling preparation and follow-up for an FDA/regulatory inspection.
Conducting a recall.
Choosing an outside vender for manufacturing operations.
Choosing an outside vendor for auditing.
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