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Advanced Aseptic Process Training

高级无菌工艺培训课程

Aseptic fill-and-finish manufacturing is the most technically challenging of all pharmaceutical manufacturing processes, requiring people trained to execute to exacting standards in a sterile environment.

PaizaBio and our partner Ausia BioTech ensure an exceptionally trained aseptic manufacturing workforce via TPA-IT, the Trans-Pacific Aseptic Institute of Training. Located on the campus of Ausia Biotech in Hangzhou, China, the $8 million dollar sterile university was originally established for Ausia BioTech employees. As TPA-IT, the curriculum have been expanded; it is now open to employees of other pharmaceutical companies, contract manufacturing organizations, and government and regulatory entities from around the world.

Training of the workforce at this comprehensive, full-scale training center ensures a staff capable of the highest level of cGMP manufacture. Training includes structured lecture and hands-on learning experiences in the principles of sterile manufacturing, quality management and regulatory compliance. 

Join us in this interactive curriculum, taught in facilities that include qualified clean rooms with fully functional HVAC systems commercial grade equipment, and a lecture hall that accommodates 50 students. The experience is designed to accelerate learning and maximize students’ retention of information and skills.

 Core Areas of Training 

Ø Theory and principles of aseptic processing

Ø Pharmaceutical engineering

Ø Sterile manufacturing

Ø Quality management

Ø Regulatory compliance

Ø Operator behavior

Ø Train the trainer

Our goal is to provide the highest quality training anywhere in the world to ensure students possess the knowledge and confidence required in the demanding environment of aseptic processing for the manufacture of sterile pharmaceutical products.

Course Description

Our third course will be held on May 18 - 19, 2017 in Hangzhou, China.

In this 2 day comprehensive training program you will learn the critical information you need to successfully operate in and manage aseptic processing areas.  With course content developed and taught by international experts, you will gain the fundamental science that is critical to understand and the basic work procedures that must be followed in order to ensure the safe production of aseptic pharmaceutical products.  The course content includes the science of how aseptic areas function, the sources of contamination, procedures for cleaning clean rooms, basic microbiology and analysis of organisms, environmental monitoring, aseptic techniques and regulatory compliance.  Our outstanding training center allows participants to learn by experience how to move and handle materials to avoid contamination and reduce risks in manufacturing.

Trainer Introduction

Our training course will be taught by Scott M Wheelwright PhD, founder and principal consultant at Complya Asia, who has over 30 years experience in pharmaceutical manufacturing and quality assurance.  Course content is provided by Anne Marie Dixon, owner and president of Cleanroom Management Associates, a world-renowned expert in aseptic processing.

The first training course held in March 2016 received almost 20 attendees from well-know companies such as WuXi AppTech, Innovent, and Tide Pharmaceutical.

The second training course held in December 2016 received more than 30 attendees from companies including Boehringer Ingelheim, Innovent, JHL, Saint-Gobain and others.

第一届培训课程于2016年3月在杭州澳亚生物成功举办,获得了很好的反馈。

第二届高级陪训班于2016年12月在杭州成功举办,来自BI、信达生物、喜康生物、圣戈班等多家公司的30余名学员参加了培训!


第三届高级培训课程亮点:

1.      课程内容由国外资深专家结合无菌工艺生产现状根据三十多年的生产经验来组织。

2.      课程由智真首席顾问亲自授课。

3.      课程在杭州澳亚生物的无菌培训中心完成,理论结合实践,在无菌模拟实践区域内实地操作, 教师随时给出纠正及建议。

4.      授课过程中应用专业培训器材进行师生互动。

5.      整整两天大容量充实无菌工艺课程,在第二届培训基础上升级。

6.  相比第一届和第二届课程,第三届高级培训课会包含实际生产过程中的实例分析等。


Registration Information

Standard registration fee is rmb 4300 per person. Each registration includes course registration/material, break refreshments, lunches and internet connectivity at the facility. Transportation (Hangzhou International Airport is the nearest airport), hotel accommodations, meals (except listed above) and other fees are not included in course registration.

标准报名价格为4300/人。注册费用包含课程注册、材料费、茶歇、午餐和网络等费用。交通、酒店住宿及早晚膳食等费用不包含在内。

优惠活动:

2017228日前报名,可享受20%优惠,即3440/人。

2016331日前报名,可享受10%优惠,即3870/人。

Group Discount 团体优惠: 

Discounts are available for multiple attendees from the same organization. Two or more attendees from the same firm receive another 10% discount on all registrations.

同公司两人或两人以上报名再享受10%优惠。

在此报名后请联系主办方付款:

邵女士

' 0512-6726 2997

* juan.shao@complya-asia.com


TRAINING ADDRESS培训地址:

Hangzhou Ausia Biological Technology Company, Ltd

杭州澳亚生物技术有限公司

Address: #1 Number 1 Street, HETZ Hangzhou, China 310018

地址:杭州(下沙)经济开发区一号大街1 邮编 310018


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活动主办方:

苏州智真生物技术咨询有限公司

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时间

2017-05-18 09:00 - 开始

2017-05-19 17:00 - 结束

已结束
地点
  • 中国 浙江 杭州市
  • 杭州(下沙)经济开发区一号大街1号