To be taught at the Ausia Biotech Aseptic Training Center in Hangzhou China

Transcription

1 Come learn from our 3-day course! Introduction to Aseptic Processing To be taught at the Ausia Biotech Aseptic Training Center in Hangzhou China March 23-25, Introduction to TPA-IT: 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 ensure 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 Aseptic manufacturing operations Aseptic facility design and engineering Quality management systems Regulatory compliance Operator behavior (hands on, in the clean room) 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. Complya Asia Page 1 of 6

2 1.1. 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 Why you should attend: Course Description 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 learn 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. 2. Introduction to our trainer and our content provider 2.1. Trainer Scott M Wheelwright PhD Cofounder and Principal Consultant, Complya Asia Co., Ltd. Scott M. Wheelwright, PhD, is cofounder, principal consultant and president of Complya Asia. His experience includes many types of pharmaceutical and life science companies, helping them meet international standards for quality. Dr. Wheelwright has technical expertise in product manufacturing, fermentation, cell culture, purification, monoclonal antibodies, proteins and viruses. He has directly participated in developing oncology, infectious disease, cardiovascular, wound healing, angiogenesis, vaccine and diagnostic products. His 30 years experience in solving the challenges companies encounter when bringing biotechnology and other medical products out of research and into the commercial marketplace and his many years in Asia enable him to support many types of challenging projects. Previously, Dr. Wheelwright served as the founding Chief Operating Officer for Innovent, a biopharmaceutical company in China developing monoclonal antibody products for sale in China and worldwide. Dr. Wheelwright has been an executive officer in several biotech start-ups, and has supervised the areas of manufacturing, process development, compliance, Quality Assurance, Quality Control, validation, engineering and facilities. He has worked as a researcher in the laboratory and has led the development of several products that are now on the market. Dr. Wheelwright has led the construction of multiple Complya Asia Page 2 of 6

3 manufacturing facilities that meet the compliance requirements for cgmp. His corporate experience includes Abbott, Chiron (now Novartis) and Scios (now Johnson & Johnson). Dr. Wheelwright obtained his PhD degree in chemical engineering from the University of California at Berkeley and performed post-doctoral studies in biophysics at the Max Planck Institute in Germany. He is the author of a book on protein purification and has published many papers on process design, manufacturing, and compliance for pharmaceuticals and biologics. He has taught numerous courses at locations around the world and is a frequently sought-after speaker at international technical conferences Training content provider Anne Marie Dixon Course content is provided by Anne Marie Dixon, owner and president of Cleanroom Management Associates, a world-renowned expert in aseptic processing. Anne Marie Dixon is owner and president of Cleanroom Management Associates, Inc., a US consulting firm that specializes in competitive benchmarking, training, and auditing of clean and aseptic operations and management. She has been actively engaged in the field of contamination control for over 35 years with extensive experience in the areas of cleanroom operations, training, technical writing, strategic consulting, facility start-up, construction protocols, and process optimization. She has trained over 850,000 cleanroom technicians and managers. Major Accomplishments 1978 Developed and tested cleanroom sanitization protocols 1979 Developed initial clean build protocols for the cleanroom industry 1980 Developed the first Cleanroom Management Training and Manuals 1983 Chairman of Institute of Environmental Sciences Recommended Practice on Cleanroom Housekeeping and Sanitization Procedures, testing and equipment. In this committee the techniques and testing of 1978 were incorporated and proven present Developed aseptic gowning techniques 1984-present Developed equipment move-in procedures 1985 Developed undergraduate course in Cleanroom maintenance and equipment installation techniques - used today at 5 major universities in the USA Chairman of Institute of Environmental Sciences Recommended Practice on Cleanroom Operations. In this committee the techniques for equipment move-in were incorporated and proven Developed and expanded clean build protocols to include 3/5 and 8 phases 1990 Chairman of conference on Particle Detection Methodology and Control President of the Institute of Environmental Sciences Complya Asia Page 3 of 6

4 1992 Chairman of conference on Mini-environments and Isolators 1993-present Chairman of the United States Technical Advisory Group to ISO Technical Committee present Head of the United States Delegation to ISO Technical Committee 209 on Cleanrooms and Associated Controlled Environments 1995 Chairman Biocontamination Control Symposium - IEST 1998 Chairman of Symposium on Cleanrooms for the Healthcare Industry (PDA and IEST) 1998 Headed research to develop new techniques for sanitization and cleaning of walls and floors in cleanrooms and controlled environments 1999 Chairman of PDA Special Scientific Forum on Environmental Monitoring 2000 Keynote address PDA Training Conference 2001 Keynote address Barnett International conference on Environmental Monitoring 2001 Updated Institute of Environmental Sciences Recommended Practice on Housekeeping and Sanitization Procedures. Included new techniques and methods as developed in Updated IEST Recommended Practice on Cleanroom Operations 2007 Updated IEST Recommended Practice on Housekeeping and Sanitization 2008 Chair of ISO TC 209 Nanotechnology Cleanroom and Controlled Environment WG Chairman RP on Controlled Environments Awards 1993 James P. Agalloco Excellence in Education 1997 Diploma in Validation Pharmaceutical Association of Mexico 1998 Fellow of the Institute of Environmental Sciences 2007 Fred Hermann Award 2010 First recipient Woman of the Year in Contamination Control 2012 Monroe Seligman Award Contamination Control Educational Programs 2013 IEST President Award Books Cleanroom Management Manual 1980, revised 1988 Guidelines for Cleanroom Management and discipline chapter 4 Noyes publication, Handbook of Contamination Control in the Microelectronics Industry 1988 isbn# Cleaning and Sanitization of Cleanrooms and Materials Marcel Dekker publication, Validation of Pharmaceutical Processes 1999 chapter 22 isbn# How to Write A Training Manual Micron Video International 1999 Personnel Training A cleanroom must Interpharm Press Sterilization of Medical Devices Editor Environmental Monitoring for Cleanrooms and Controlled Environments Informa USA isbn# Complya Asia Page 4 of 6

5 2007 Confronting Variability, editor R. Prince, chapter 2 People, Training and Variability, DHI International.isbn# Aerosol Measurement Principles, Techniques and Applications, editor Pramod Kulkari, Paul Al. Baron, Klaus Willeke John Wiley&Sons Publication, isbn# chapter 36 Aerosol Measurement in Cleanrooms, David S. Ensor and Anne Marie Dixon 2010 Cleaning and Cleaning Validation Informa USA 2009 Paul Pluta editor chapter 11 Cleaning of Non-Product Contact Surfaces isbn# Contamination Control in Healthcare Product Manufacturing, Volume 1 Russell Madsen and Jeanne Moldenhauer Editors, DH Publishing, 2013, ISBN# Chapter 5 Facility Design and Control: Personnel; Chapter 6 Facility Design and Control: Cleaning and Sanitization 3. Training center Located on the campus of Ausia Biotech in Hangzhou China, the $8 million dollar sterile university was originally established for employees of Ausia BioTech (the largest aseptic filling CMO in China). As part of 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. Below are pictures from this training center. You can find more information on the website The facility is a state-of-the-art training center with a modern auditorium for lectures and discussion. Complya Asia Page 5 of 6

6 The facility includes fully functioning cleanrooms with filling equipment, which enables each participant to practice aseptic techniques, including gowning and visualization of movement in class 100 areas through smoke testing and video recording. Learn first hand how air patterns behave under laminar flow! 4. Contact information: Juan Shao: Telephone: office; mobile Registration website: Complya Asia Page 6 of 6