为进一步加强中国制药工程领域同仁与国际权威专家的学术研讨交流，ISPE中国 现特别邀请到指南认证讲师来华举办主题沙龙。正版授权!
现场讲者学员多维互动，利于开拓思路；资深行业专家助教，利于学习实战经验。分别在北京、上海各举办一场：
北京场：7月13-14日（周六—周日）
上海场：7月16-17日（周二—周三）
名称:《ISPE 无菌工艺和欧盟GMP附录1(T63)主题沙龙》
主讲:Norman A. Goldschmidt
时长:2天
标准价格:
7000元/人 2天
ISPE会员价:5600元/人 2天
多人报名折扣(需同一家公司，同一天订单)：
3-4人 →9折,折扣码:PV90
5人以上 →85折,折扣码:PV85
发票仅可开具:会议服务费
参加完整两天培训，可获取授课讲师签署颁发的证书，并在“ISPE中国”官网上可查询
Day1 & Day2
8:30-9:00 签到注册
9:00-10:00 Classroom Training
10:00-10:30 Refreshment Break
10:30-12:00 Classroom Training
12:00-13:00 Lunch
13:00-14:30 Classroom Training
14:30-15:00 Refreshment Break
15:00-17:00 Classroom Training
加入中国医药设备工程协会会员，请跳转http://www.cpape.org.cn/
概 述
Driven by biopharmaceuticals but also prominent in small molecules drug manufacturing as well as for APIs, aseptic processing will undergo a technology jump start driven by the new EC GMP Guide Annex 1. Globally supplying companies, which deliver drugs to Europe, must comply with this new regulatory requirement. There is an impact for all stakeholders of manufacturing, across hierarchy levels and various functions at manufacturers. Also, suppliers have to consider Annex 1 when supplying new equipment or installing new production facilities.
不仅源于生物制药的推动，且在小分子药物和原料药生产方面也很有优势的无菌工艺将在新的欧盟GMP指南附录1的推动下经历一次技术飞跃。向欧洲供应药品的全球的制药公司必须遵守这一新的监管要求。其对制药业的所有利益相关者都有影响，影响更是跨越制药公司的层级和各种职能。此外，制药公司在采用新设备或建设新的生产设施时，必须考虑欧盟GMP附录1。
This course will focus on aseptic processing and quality management around the most important pharmaceutical technology.
本沙龙将围绕最重要的制药技术，重点介绍无菌工艺和质量管理。
你将学到什么
Upon completing this course, you will be able to:
完成本课程后，您将能够:
Understand the new EC GMP Guide Annex 1 and its impact on future aseptic processing
了解新的欧盟GMP指南附录1及其对未来无菌工艺的影响
Determine the current industry standards for manufacturing and environmental control
确定药品生产和环境控制的现行行业标准
Engage in critical topics discussion in regulators inspections
参与监管机构检查中的关键话题讨论
课程模块
Introduction to the Regulatory Framework
法规框架介绍
Hot Topics from Annex 1
欧盟GMP附录1中的热门话题
Interaction of Process and Aseptic Fill/Finish Operations
工艺和无菌灌装/成品操作的相互作用
Principles of Aseptic Processing
无菌工艺原则
Process Development and Validation
工艺开发和验证
Quality Risk Management
质量风险管理
Training Systems
培训系统
Interactive Session/Case-Based Learning
交互式会话/基于案例的学习
How to Prepare for Regulatory Inspections
如何准备监管检查
目标人群
?Managers of production and quality assurance
生产经理和质量保证经理
? Process engineers 工艺工程师
? Engineers responsible for infrastructure and maintenance 负责基建和维护的工程师
? Quality managers 质量经理
? Shop floor supervisors基层主管
? Middle management中层管理者
? Department heads部门主管
? Suppliers for equipment and infrastructure of aseptic manufacturing plants
无菌药品生产工厂的设备和基建供应商
主讲专家
- Norman A. Goldschmidt -
President
Genesis AEC
Norman Goldschmidt is President of Genesis Architects, Engineers & Constructors. He has over 35 years of experience in engineering management, planning, design and construction in the pharmaceutical and biotech industry.
Prior to joining Genesis, Norman served in numerous capacities during 20 years with Bristol-Myers Squibb (BMS). Starting as a Mechanical Engineer / Project Manager and culminating as Executive Director, Global Engineering for Strategy and Design. His industry experience spans the many types of facilities and processes necessary to bring a drug to market - from R&D through Manufacturing.
Mr. Goldschmidt studied Engineering Management at the State University of New York and Mechanical Engineering at the University of Buffalo. He holds 4 patents for innovations in HVAC and Pharmaceutical Processing, is an International Standards Organization (ISO) Author/Expert, Adjunct Professor at the New Jersey Institute of Technology, Lead/Contributing Author on 8 ISPE Guides well as author, contributor and instructor for ISPE, ASHRAE, NSF, FDA, HCA, TGA and others.
参会报名
席位限定，报名从速
费用（含研讨、午餐）
参会费用
?标准价格：7000元/人 2天
?ISPE会员价：5600元/人 2天
?多人报名折扣（需同一家公司，同一天订单）
?3- 4人 ? 9折 折扣码：PV90
?5人以上? 85折 折扣码：PV85
?会务咨询，孙老师13811463324（微信同号）
?发票仅可开具：会议服务费
?参加完整两天培训，可获取授课讲师签署颁发的证书，并在ISPE中国官网上可查询
培训汇款：
汇款信息
名称：中国医药设备工程协会
开户银行：中国工商银行北京新街口支行
账户：0200002909014409855
*汇款时请注明：ISPE培训
北京场
时间：2024年07月13-14日（周六—周日）8:30-17:00
地点：北京市经开区科创十三街18号院锋创科技园5号楼一层锋创礼堂
扫描以下二维码，报名北京场：
上海场
时间：2024年07月16-17日（周二—周三）8:30-17:00
地点：上海市浦东新区环科路555号1号楼 霍尼韦尔总部大楼
扫描以下二维码，报名上海场：
欢迎您的参会
中国医药设备工程协会年会连续举办了13届，本次是第十四届年会，同期举办中国医药设备工程协会第八次会员大会暨八届一次理事会。
请扫码海报上的二维码，了解年会参会要求，提前报名，锁定行业高端学术和思想盛会、业务拓展良机。