摘要
目的:探讨药品GMP检查员分级管理制度下的培训方式。方法:简要介绍本市药品GMP检查员分级管理制度,分析了分级制前传统培训方式及其优缺点,提出了对不同级别检查员开展针对性、层次性的培训需求。结果:传统培训方式不能满足不同级别检查人员对理论知识、能力素质的不同要求;提出了针对不同级别检查员开展的各种广度和深度的培训方式。结论:结合岗位任职和监管需求提出分级制下的培训方式和培训目的,以期对实施有实用性、针对性的岗位培训有一定借鉴意义,从而提高药品检查的专业性、针对性、有效性。
Objective： To discuss the training method under the classification management system of GMP inspectors. Methods： the classification management system of GMP inspectors in Shanghai was briefly introduced, the pros and cons of the traditional training methods were analyzed and training requirements of different level inspectors were proposed. Results：Various breadth and depth training methods for different levels of inspectors were proposed because the traditional training method could not meet the various requirements of theoretical and practical knowledge under the classification management system. Conclusion： Methods and target for training under the classification management system are proposed considering both position and regulatory requirements so as to have certain reference value for practical and targeted job training and to improve the professionalism, pertinence and effectiveness of drug inspection.
作者
俞佳宁
柳涛
韦欣
YU Jianing;LIU Tao;WEI Xin(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China;Shanghai Pharmaceuticals Holding Co.,Ltd.,Shanghai 200020,China)
出处
《上海医药》
CAS
2018年第11期75-78,共4页
Shanghai Medical & Pharmaceutical Journal
