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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Marci Macpherson, Bridget Foltzand 3 more

March 1, 2010

1 Min Read
RA/QA/QC Responsibilities
  • 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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