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应用统计分析,助力质量提升_王欣明

演讲嘉宾:王欣明,华北制药股份有限公司质量管理部部长

演讲主题:应用统计分析,助力质量提升

演讲摘要:

王部长将通过多个案例阐述统计分析在产品质量回顾、日常质量管理(包括实验室数据分析、预防性管理、变更管理等)、验证管理、产品稳定性考察和药物警戒中的实践应用, 并充分运用JMP拟合分布、拟合模型、统计过程控制分析、变异性分析、退化、稳定性检验、筛选、文本分析与挖掘等科学的分析方法在药品质量管理各阶段的广泛应用,确保药品质量和工艺的稳定性与可靠性,从而满足监管机构严格的管理要求,为药品推向市场提速增效。