China’s only sterile university dedicated to training the aseptic workforce
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.
Our next course will be held on March 23-25, 2016 in Hangzhou, China.
In this course you will learn the critical information you need to 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. The course will be of value to operators, managers, engineers, quality assurance and quality control personnel.
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.
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。
Standard registration fee is rmb 6700 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.
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.
' 0512-6726 2997
Hangzhou Ausia Biological Technology Company, Ltd
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号 邮编 310018