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So what happens once you have submitted your report? Once they are reported, quality complaints and adverse events are handled very differently and by different teams. If it is a quality complaint, the report is handled by the Quality Assurance Unit. They will start by tracking the issue to see if it is a trend or an isolated incident. This is why it is important that all quality complaints be reported, whether we believe them to be important or not. The data is reviewed in order to identify trends or potential issues, which may trigger an investigation. Quality complaints are also reported to the veto, Ken Management and to regulatory authorities. As required, if an investigation is warranted, the Quality Assurance team will follow up with the manufacturer of the product, review their batch records, and address the issues that were reported in order to resolve those complaints. This process helps to ensure we continue to provide high quality products to our customers. If the report was for an adverse event, the US Regulatory Affairs team responsible for pharmacovigilance will investigate the event, determine the severity of the case, and depending on the product, submit the adverse event to the appropriate regulatory authority. FDA or Ask Every adverse event is investigated with the customer to gather information about the individual case. All data is reviewed in order to identify trends or potential issues, and findings are reported to veto Ken Management and the appropriate regulatory authorities. Timing is of the essence. You must report an adverse event within two days in order to meet veto Ken's requirements. To learn more about quality complaints and adverse events, reporting and processes, there are two SOPs that go into further details. You can find them in Quality Sphere US, SOP 0 0 8 2 Adverse Event Reporting, and USS OP 0 0 8 1 Quality Complaints Planes.