ICH Q10 recommends that Management Reviews be performed in order to assure that process performance and product quality are managed over the life-cycle. The management review process should include the results of regulatory inspections and other audits, measures of customer satisfaction such as product quality complaints and recalls, conclusions of process performance and product quality monitoring, and the effectiveness of process and product changes.
PSC can help you structure the management review process to ensure that your senior management team is apprised of your quality system in a concise and expeditious manner. Specifically, we can assist you in:
- Structuring a concise, comprehensive, and effective review process that includes areas to be addressed, documents required, an effective presentation format, and documenting and tracking action items as a result of the review.
- Addressing regulatory inspection observations and other audit findings, including liaison with regulatory bodies and recommendations for remedial actions.
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