Aseptic Processing & Annex 1 Training Course

无菌工艺及欧盟GMP附录1 主题沙龙

Aseptic Processing & Annex 1 (T63) – New Course!

无菌工艺和欧盟GMP附录1（T63）- 新沙龙！


Overview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.

本课程将围绕最重要的制药技术，重点介绍无菌工艺和质量管理。


What You Will Learn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


Resources and Activities资源和活动

  • Pre-Course Work Materials课前作业材料
  • Interactive Exercises互动练习
  • Learning Assessments学习评估
  • EU Annex 1 欧盟附录1
  • FDA CFR 210 and 211美国药品GMP（FDA 21CFR 210和211）


Course Modules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


Who Should Attend谁应该参加

  • 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