Speakers: Wang Xinming, Head of Quality Management Department, North China Pharmaceutical Co., Ltd.
the speech topic : Apply statistical analysis to help improve quality
Summary of speech:
Minister Wang will illustrate the practical application of statistical analysis in product quality review, daily quality management (including laboratory data analysis, preventive management, change management, etc.), verification management, product stability inspection and pharmacovigilance through multiple cases, and Make full use of JMP fitting distribution, fitting model, statistical process control analysis, variability analysis, degradation, stability test, screening, text analysis and mining and other scientific analysis methods in various stages of drug quality management to ensure drug quality And the stability and reliability of the process, so as to meet the strict management requirements of the regulatory agencies, and speed up the introduction of drugs to the market.
