由德国弗戈工业媒体主办的“2015弗戈制药工程国际论坛”于6月4日在江苏泰州举行。论坛汇集PROCESS《流程工业》杂志全球(德文版、英文版、印度版)力量，采用主会场与分论坛相结合，力求营造重点突出、主题明确的专业学术氛围。以下是恩宜珐玛(天津)工程有限公司项目经理谢京军先生在2015弗戈制药工程国际论坛上关于“FDA设施设备新要求解读——ASTM E2500的实施”的发言。

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图2演讲现场

关于谢京军先生：

恩宜珐玛(天津)工程有限公司担任调试与确认和GMP合规高级专家

谢京军有超过15年的制药和生物技术行业内的药品生产及咨询服务经验。目前他在恩宜珐玛(天津)工程有限公司担任调试与确认和GMP合规高级专家，曾担任过过项目质量经理、项目经理和质量经理。在加入恩宜珐玛公司之前，他在天津百特医疗用品有限公司担任过仓库主管、计划专员和生产主管，在博福-益普生(天津)制药有限公司担任过验证专员和质量保证工程师，具有药厂生产、质量保证、物流等方面的经验。他曾参与了许多工程投资项目，负责GMP合规、调试和确认执行。他是中国食品药品监督管理总局高级研修学院客座教授。也是国际制药工程协会中国理事会的理事。

Pete has more than 15 years production and consultant experience in pharmaceutical and biological industry. Now he is the senior specialist, commissioning & qualification and GMP compliance. He has been as project quality manager, project manager and quality manager. Before joining NNE Pharmaplan, Pete acted as warehouse supervisor, planner and production supervisor in Baxter. He also acted as validation specialist and QA engineer in Beufour-Ipsen. He had much experience in production, quality assurance and logistic. He has been involved in many engineering project and was responsible for GMP compliance, commissioning and qualification. He is the CFDA Institute of Executive Development and member of ISPE China board of directors.