Trans-Pacific Aseptic Institute of Training

(TPA-IT)跨太平洋无菌培训学院

培训班March 23 – 25, 2016

Hangzhou, China

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.

Complya Asia, 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 has been expanded and is now open to employees of other pharmaceutical companies, contract manufacturing organizations, and government and regulatory entities from around the world.

Training of your workforce at this comprehensive, full-scale training center will ensures a staff capable of the highest level of cGMP manufacturing. 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 student retention of information and skills.

Core Areas of Training Theory and principles of aseptic processing Pharmaceutical engineering Sterile manufacturing Quality management Regulatory compliance Operator behavior

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 product.

TPA-IT INTRODUCTION

Who Should Attend?We recommend this course for individuals at all levels who are responsible for aseptic manufacturing, including management, filling-line supervisors, QA and QC specialists, microbiology specialists, and facility engineers.

Course Description:Our next course will be held on March 23 – 25, 2016 in Hangzhou, China.

In this 3 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

COURSE DETAILS

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.

HOW TO REGISTER: http://tpait88.eventdove.comPlease find the registration form on the website (http://tpait88.eventdove.com), fill in the registration

form and submit online. We will contact you regarding details and payment. http://tpait88.eventdove.com

0512-6726 2997

juan.shao@complya-asia.com

Scott M Wheelwright PhD

PRICING AND REGISTRATION INFORMATIONSTANDARD PRICE BEST VALUE!

Early Registration Rates by January. 15, 2016 ￥5,360

Advance Registration Rates until Feb. 19, 2016 ￥6,030

Standard Registration Rates after Feb. 19, 2016 ￥6,700

TRAINING SCHEDULE

Course One: Wednesday – Friday, March 23 – 25, 2016

Day 1: Basic GMP, cleanrooms, staffing, cleaning and sanitization

Day 2: Basic microbiology, environmental monitoring, and operations

Day 3: Hands-on practice with video for gowning and clean room activities

GROUP DISCOUNTSGroup Discount: 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.

ADDITIONAL REGISTRATION DETAILSEach registration includes course registration, material, break refreshments, lunches and

internet connectivity at the facility. Space is limited so early registration is advised.

TRAINING ADDRESS

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 号 邮编 310018

Transportation:

杭州火车站 — 澳亚生物： 乘坐地铁 1 号线 (下沙江滨方向), 在高沙路站下车(D 口出)；约 20 公里，乘出租车费用约 50 元。萧山国际机场 — 澳亚生物：约 26 公里，乘出租车费用约 65 元。