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

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "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

JOHN M. LINDSAY, SM (ACM) P.O. Box 219 El Granada, CA (650)

JOHN M. LINDSAY, SM (ACM) P.O. Box 219 El Granada, CA (650) , SM (ACM) P.O. Box 219 El Granada, CA 94018 (650) 560-9125 QUALIFICATIONS 20 years management experience (28 years total experience) for three of nation s leading pharmaceutical companies. Currently,

More information

On-Site GMP Training GMP COMPLIANCE TECHNICAL

On-Site GMP Training GMP COMPLIANCE TECHNICAL PharmaNet On-Site GMP Training GMP COMPLIANCE TECHNICAL 284 E Lake Mead Pkwy Suite C-278 Henderson, NV 89015 Phone: 702-558-0094 Fax: 702-558-0079 www.gmpseminars.com Key to Level of Program Level A: Program

More information

Raleigh, NC May 12 th & 13 th 2016. Meeting The New ISO Cleanroom Standards And Changing EU Guidance How Will You Comply?

Raleigh, NC May 12 th & 13 th 2016. Meeting The New ISO Cleanroom Standards And Changing EU Guidance How Will You Comply? Raleigh, NC May 12 th & 13 th 2016 Meeting The New ISO Cleanroom Standards And Changing EU Guidance How Will You Comply? The International Cleanroom Standards (ISO 14644-1 & 2) have been updated, these

More information

Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH

Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH VWR enables the advancement of science by providing high-quality chemicals and services, customized to your

More information

INTEGRATING COMPLIANCE, CLEANLINESS, AND SAFETY IN CONTROLLED ENVIRONMENTS CONTROLLED ENVIRONMENTS MANAGEMENT SERVICES

INTEGRATING COMPLIANCE, CLEANLINESS, AND SAFETY IN CONTROLLED ENVIRONMENTS CONTROLLED ENVIRONMENTS MANAGEMENT SERVICES INTEGRATING COMPLIANCE, CLEANLINESS, AND SAFETY IN CONTROLLED ENVIRONMENTS CONTROLLED ENVIRONMENTS MANAGEMENT SERVICES Because Clean is Critical Technological advancement, rapid change, and high quality

More information

Pharmaceutical. Facility Design. Full Time Part Time Online.

Pharmaceutical. Facility Design. Full Time Part Time Online. Pharmaceutical Facility Design Full Time Part Time Online www.getreskilled.com Contents 1. Welcome 2. Program Overview 3. Program Content 4. Pharmaceutical Facility Design www.getreskilled.com 2 Welcome

More information

Principles. of Pharmaceutical Facility Design. Full Time Part Time Online. www.dpseng.com.sg

Principles. of Pharmaceutical Facility Design. Full Time Part Time Online. www.dpseng.com.sg Principles of Pharmaceutical Facility Design Full Time Part Time Online www.dpseng.com.sg Contents 1. Welcome 2. Programme Overview 3. Programme Content www.dpseng.com.sg 2 Welcome Transition into a new

More information

Practical Series Seminars and Workshops INTENSIVE TRAINING IN ENVIRONMENTAL MONITORING, DISINFECTANT QUALIFICATION AND CLEANROOM CONTAMINATION CONTROL

Practical Series Seminars and Workshops INTENSIVE TRAINING IN ENVIRONMENTAL MONITORING, DISINFECTANT QUALIFICATION AND CLEANROOM CONTAMINATION CONTROL QUALIFICATION AND CLEANROOM CONTAMINATION CONTROL Who should attend: Quality Assurance, Quality Control, Operations, Regulatory and Manufacturing Supervisors, Cleanroom Operators and Facilities Personnel

More information

A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program

A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program Shaping Human Capital for Challenges in the Pharmaceutical Industry CLEANING VALIDATION Instructors Loh Kean Chong Rick Ng Date and Time

More information

A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program

A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program Shaping Human Capital for Challenges in the Pharmaceutical Industry PROJECT MANAGEMENT: RENOVATION OF RESEARCH LABORATORY FOR CELL CULTURE

More information

ISPE NORDIC is pleased to invite You to a conference. Critical Utilities. Commissioning, Qualification and Sampling New Guides from ISPE

ISPE NORDIC is pleased to invite You to a conference. Critical Utilities. Commissioning, Qualification and Sampling New Guides from ISPE ISPE NORDIC is pleased to invite You to a conference Critical Utilities Commissioning, Qualification and Sampling New Guides from ISPE Date: 27 April 2015 Venue: Fyrislund, Uppsala Who should attend? Process

More information

Montgomery County Community College BIT 123 Techniques and Instrumentation for Biotechnology 4-3-3

Montgomery County Community College BIT 123 Techniques and Instrumentation for Biotechnology 4-3-3 Montgomery County Community College BIT 123 Techniques and Instrumentation for Biotechnology 4-3-3 COURSE DESCRIPTION: This course will allow students to gain theoretical and practical, hands-on knowledge

More information

& Agalloco Associates

& Agalloco Associates Course Descriptions STERILIZATION: PRINCIPLES AND VALIDATION ASEPTIC PROCESSING: A COMPREHENSIVE REVIEW Take Either Course or Save on Both MAY 2-6, 2016, COPENHAGEN, DENMARK Sterilization: Principles and

More information

On-Site GMP Training GMP COMPLIANCE TECHNICAL

On-Site GMP Training GMP COMPLIANCE TECHNICAL PharmaNet On-Site GMP Training GMP COMPLIANCE TECHNICAL 284 E Lake Mead Pkwy Suite C-278 Henderson, NV 89015 Phone: 702-558-0094 Fax: 702-558-0079 www.gmpseminars.com Key to Level of Program Level A: Program

More information

BIOTECHNOLOGY. Bouvé College of Health Sciences College of Science. Networked for Success. Networked for Industry. Networked for Life.

BIOTECHNOLOGY. Bouvé College of Health Sciences College of Science. Networked for Success. Networked for Industry. Networked for Life. MASTER OF SCIENCE BIOTECHNOLOGY Networked for Success. Networked for Industry. Networked for Life. Bouvé College of Health Sciences College of Science Northeastern s Biotechnology Masters program synthesizes

More information

ENVIRONMENTAL TESTING & MONITORING: Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers A WHITE PAPER

ENVIRONMENTAL TESTING & MONITORING: Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers A WHITE PAPER A WHITE PAPER ENVIRONMENTAL TESTING & MONITORING: Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers By Scott Mackin A WHITE PAPER ENVIRONMENTAL TESTING & MONITORING:

More information

Biopharmaceutical Process Evaluated for Viral Clearance

Biopharmaceutical Process Evaluated for Viral Clearance Authored by S. Steve Zhou, Ph.D. Microbac Laboratories, Inc., Microbiotest Division The purpose of Viral Clearance evaluation is to assess the capability of a manufacturing production process to inactivate

More information

2010 Critical Thinker Series

2010 Critical Thinker Series Malaysian Organisation of Pharmaceutical Industries (MOPI) & PharmEng Technology Presents cgmp Case Studies a T rra ini ing i P rrog rram ffo rr cgmp P rro ffe ss ss ionai l ss 2010 Critical Thinker Series

More information

NATIONAL SALES DIRECTOR LORI ANN SWISHER Phone:

NATIONAL SALES DIRECTOR LORI ANN SWISHER Phone: Curriculum Vitae NATIONAL SALES DIRECTOR LORI ANN SWISHER Phone: 419-350-9727 Summary of Qualifications Lori has over 25 years of technical experience in the quality control and regulatory compliance within

More information

Good Laboratory Practices

Good Laboratory Practices National University of Singapore Academy of GxP Excellence (NUSAGE) & PharmEng Technology Presents Good Laboratory Practices and B iosafety C onsiderations Part of the Pharmaceutical and Biotechnology

More information

LIFE SCIENCES QUEENSLAND LIMITED (LSQ) Mario Pennisi CEO. @LSQld

LIFE SCIENCES QUEENSLAND LIMITED (LSQ) Mario Pennisi CEO. @LSQld LIFE SCIENCES QUEENSLAND LIMITED (LSQ) Mario Pennisi CEO @LSQld LEADING DESTINATION FOR CLINICAL RESEARCH INVESTORS IN QLD INCLUDE: LIFE SCIENCES IN QLD ~300 companies in life sciences ~$5B invested by

More information

Cleanrooms & Containment Facilities: An Introduction

Cleanrooms & Containment Facilities: An Introduction Cleanrooms & Containment Facilities: An Introduction Presentation by Steve Heyes 3 rd October 2012 Business Profile Delivery of operationally critical facilities & systems based on a design build or design

More information

Biopharmaceutical Contract Manufacturing

Biopharmaceutical Contract Manufacturing S TAT E N S S E R U M I N S T I T U T Biopharmaceutical Contract Manufacturing Your Requirements Our Commitment UnderTitel SSI-Image-Brochure.indd Sec2:1 1 05-07-2007 07:31:31 Introduction Statens Serum

More information

Biotechpharma company profile

Biotechpharma company profile Biotechpharma company profile October 2013 1 History 2004 Biotechpharma UAB established as a proteomic research company in Vilnius, Lithuania 2005 Company became a member of UK s Northway group, investing

More information

Qualification of an Environmental Monitoring Program

Qualification of an Environmental Monitoring Program [ Scott Sutton Qualification of an Environmental Monitoring Program Scott Sutton Microbiology Topics discusses various topics in microbiology of practical use in validation and compliance. We intend this

More information

Creating a cgmp Facility for Early Clinical Trials of Molecular Imaging and Therapeutic Agents

Creating a cgmp Facility for Early Clinical Trials of Molecular Imaging and Therapeutic Agents Designing for the Frontiers of Research Creating a cgmp Facility for Early Clinical Trials of Molecular Imaging and Therapeutic Agents Richard J. Mohr What if it were possible to treat a cancer patient

More information

Training and Employment Opportunities in the Biopharma Industry

Training and Employment Opportunities in the Biopharma Industry 014 Training and Employment Opportunities in the Biopharma Industry In association with Employment Opportunities What are the Job Opportunities in the Biopharma Industry? The strong flow of investment

More information

Process engineer aboutbioscience.org/process_engineer.html. Process technician aboutbioscience.org/process_technician.html

Process engineer aboutbioscience.org/process_engineer.html. Process technician aboutbioscience.org/process_technician.html Exciting career opportunities exist for students who are interested in working in the biopharmaceutical industry and making a positive contribution to the lives of millions of people who will benefit from

More information

Bachelor s Degree. in Manufacture of Medicinal Products (DT291) Full Time Part Time Online. www.getreskilled.com

Bachelor s Degree. in Manufacture of Medicinal Products (DT291) Full Time Part Time Online. www.getreskilled.com Bachelor s Degree in Manufacture of Medicinal Products (DT291) Full Time Part Time Online www.getreskilled.com Contents 1. Welcome 2. Program Overview 3. Program Content 4. Core Modules 5. Optional Modules

More information

Join our scientific talent community

Join our scientific talent community Join our scientific talent community There has never been a better time to be a part of Janssen Research & Development. We are at the forefront of healthcare leading, evolving and transforming it into

More information

Risk Based Environmental Monitoring (EM) and EM Data Management and Trending

Risk Based Environmental Monitoring (EM) and EM Data Management and Trending Risk Based Environmental Monitoring (EM) and EM Data Management and Trending An Industry Roundtable Discussion Marsha Stabler Hardiman and Parsa Famili March 11, 2015 PDA NE Chapter Meeting Presenters

More information

An Interactive Two-Day Program. Manufacturing and Quality Requirements for Biotech Drug Products to Meet the New Worldwide Requirements

An Interactive Two-Day Program. Manufacturing and Quality Requirements for Biotech Drug Products to Meet the New Worldwide Requirements An Interactive Two-Day Program Manufacturing and Quality Requirements for Biotech Drug Products to Meet the New Worldwide Requirements REGISTER EARLY! Mainz, Germany 13 14 October 2015 Hyatt Regency Mainz

More information

NEBB Cleanroom Performance Testing Certified Professional Seminar and Exams

NEBB Cleanroom Performance Testing Certified Professional Seminar and Exams NEBB Cleanroom Performance Testing Certified Professional Seminar and Exams October 20-22, 2014 Orlando, FL Introduction Cleanroom testing must be performed to ensure that cleanrooms comply with design

More information

Aseptic preparations, including TPN, for a limited number of patients

Aseptic preparations, including TPN, for a limited number of patients Aseptic preparations, including TPN, for a limited number of patients Group F (TPN) 1 Objective Presentation of our business case: setting up an aseptic TPN production in the Hilton Pharmacy instead of

More information

patient safety A commitment to GE Healthcare

patient safety A commitment to GE Healthcare GE Healthcare A commitment to patient safety GE Healthcare is committed to providing radiopharmaceuticals that are compounded and dispensed accurately. Quality assurance and patient safety are the cornerstones

More information

LIBRARY GUIDE: Pharmaceutical GMPs

LIBRARY GUIDE: Pharmaceutical GMPs LIBRARY GUIDE: Pharmaceutical GMPs Table of Contents Overview............................................................................ 3 Courses Listed by Functional Area....................................................

More information

Workflow System for Paperless Air Monitoring Powered by MODA. Presented by

Workflow System for Paperless Air Monitoring Powered by MODA. Presented by Introducing Hach s MET ONE Compliance Workflow System for Paperless Air Monitoring Powered by MODA Presented by Scott Hjelmervik Bob Toal Systems Director Vice President Hach Company MODA Technology Partners

More information

Eden Biodesign ebook Monoclonal Antibody Production: Building the Platform

Eden Biodesign ebook Monoclonal Antibody Production: Building the Platform Eden Biodesign ebook Monoclonal Antibody Production: Building the Platform CHAPTER 1: Overview CHAPTER 2: Challenges CHAPTER 3: Purification Methodology CHAPTER 4: Results CHAPTER 5: About Eden Biodesign

More information

GUIDELINES TO THE LEVEL TWO CERTIFICATION IN FOOD PROTECTION

GUIDELINES TO THE LEVEL TWO CERTIFICATION IN FOOD PROTECTION GUIDELINES TO THE LEVEL TWO CERTIFICATION IN FOOD PROTECTION 6/2013 Certification in Food Protection Guidelines Page 1 of 11 TABLE OF CONTENTS SECTIONS PAGE NUMBER MISSION STATEMENT 2 I. DEFINITIONS 3

More information

ICH Q7 GMP for Active Pharmaceutical Ingredients

ICH Q7 GMP for Active Pharmaceutical Ingredients National University of Singapore Academy of GxP Excellence (NUSAGE) and PharmEng Technology Presents ICH Q7 GMP for Active Pharmaceutical Ingredients Part of the Pharmaceutical Biotechnology Training Courses

More information

BIOTECHNOLOGY & COMPLIANCE Associate in Science Degree

BIOTECHNOLOGY & COMPLIANCE Associate in Science Degree BIOTECHNOLOGY & COMPLIANCE The Biotechnology Program is designed to prepare students for entry-level positions in the biomanufacturing industry. Students will develop a broad laboratory science-based background

More information

Environmental Monitoring of Clean Rooms

Environmental Monitoring of Clean Rooms Environmental Monitoring of Raul Duarte President DDK Scientific, Corp. Copyright DDK Scientific, Corp. 2008, 2009, DDK Scientific, Corp. Proprietary A manufacturing facility for pharmaceutical products

More information

From Research Services and Process Development to GMP Manufacturing

From Research Services and Process Development to GMP Manufacturing From Research Services and Process Development to GMP Manufacturing P a r ag o n B i o s e r v i c e s, I n c. A contract research and GMP manufacturing organization (CMO) with a focus on the development

More information

Joy Doran-Peterson, Director MBB Program www.biomanufacturing.uga.edu. A degree program of the UGA Biomedical and Health Sciences Institute

Joy Doran-Peterson, Director MBB Program www.biomanufacturing.uga.edu. A degree program of the UGA Biomedical and Health Sciences Institute Training the Next Generation of Fermentation Scientists at UGA via the Professional Science Master of Biomanufacturing and Bioprocessing Or Using Your Resources to Answer a Wake-up Call Joy Doran-Peterson,

More information

Debbie M. Craver Brown, RN, MSN Senior Associate Clemmons, North Carolina 336.766.2761 or 336.692.2279 Email: debbrown55@triad.rr.

Debbie M. Craver Brown, RN, MSN Senior Associate Clemmons, North Carolina 336.766.2761 or 336.692.2279 Email: debbrown55@triad.rr. CURRICULUM VITAE Debbie M. Craver Brown, RN, MSN Senior Associate Clemmons, North Carolina 336.766.2761 or 336.692.2279 Email: debbrown55@triad.rr.com Prior Accomplishments and Experience Deborah Brown

More information

Library Guide: Pharmaceutical GMPs

Library Guide: Pharmaceutical GMPs Library Guide: Pharmaceutical GMPs Table of Contents Overview...3 Courses Listed by Functional Area... 4 Course Descriptions: A Step-by-Step Approach to Process Validation (PHDV79)... 7 A Tour of the FDA

More information

PEOPLE > SCIENCE > SOLUTIONS

PEOPLE > SCIENCE > SOLUTIONS PEOPLE > SCIENCE > SOLUTIONS Our difference Our foundation Our focus ANALYTICAL CHEMISTRY & MATERIALS CHARACTERIZATION EFFICACY (Functional testing) BIOCOMPATIBILITY (in vivo & in vitro toxicology) CLINICAL

More information

Providing Trusted and Innovative Solutions t o the Life Science Communities

Providing Trusted and Innovative Solutions t o the Life Science Communities Providing Trusted and Innovative Solutions t o the Life Science Communities Eurogentec Eurogentec is a leading supplier of trusted and innovative reagents, kits, specialty products and custom research/development

More information

SIPBS Portfolio. 2012-13 Entry

SIPBS Portfolio. 2012-13 Entry SIPBS Portfolio 2012-13 Entry MSc Programmes Existing: MSc Pharmaceutical Analysis MSc Analysis of Medicines (distance learning) MSc Clinical Pharmacy New Programmes just launched for Sept 2012 entry:

More information

CURRICULUM VITAE. 1231 Conches (Swtzerland) 0041-76-316.10.38 (personal assistant) Private phone number 0041-22-830.15.45

CURRICULUM VITAE. 1231 Conches (Swtzerland) 0041-76-316.10.38 (personal assistant) Private phone number 0041-22-830.15.45 1Curriculum vitae F.A. Waldvogel, M.D. 1 CURRICULUM VITAE WALDVOGEL Francis A. Origin Geneva (Switzerland) Date of birth October 19, 1938 Languages French, German, English (fluent) Italian (good understanding)

More information

Lean Strategies for Laboratory Testing

Lean Strategies for Laboratory Testing Microrite, Inc. brings you this unique learning experience in Lean Strategies for Laboratory Testing; Part of Microrite s step-by-step webinar series. Lean Strategies for Laboratory Testing erience in

More information

Aseptic Processing for Today and Tomorrow

Aseptic Processing for Today and Tomorrow Program Managers: Justin Cantor, PSC Biotech Merritt Postma, IMALife Location: DPR Newport Beach 4665 MacArthur Court, Suite 100 Newport Beach, California 92660 ISPE Greater Los Angeles Chapter Invites

More information

Job Description. Regularly reviews workflow operations and ensures contracted KPIs and service standards are met.

Job Description. Regularly reviews workflow operations and ensures contracted KPIs and service standards are met. Job Description Job Title: Location: Reporting to: Accountable to: Microbiology Service Lead TDL North West London TDL Microbiology Head of Department TDL Group Laboratory Director Job Summary: Responsible

More information

Barrier and isolation systems

Barrier and isolation systems VOLUME 21, NO. 04, APRIL 2007 T H E M A G A Z I N E O F C O N T A M I N A T I O N C O N T R O L T E C H N O L O G Y Barrier and isolation systems INTERPHEX 2007 Showguide Ventilation and exhaust systems

More information

This article discusses the challenges that can be

This article discusses the challenges that can be Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science Volume 10, Number 4, 2012 ª Mary Ann Liebert, Inc. DOI: 10.1089/bsp.2012.0054 Establishing a National Biological Laboratory Safety

More information

exactly. The need for efficiency in developing effective new therapeutics has never been greater.

exactly. The need for efficiency in developing effective new therapeutics has never been greater. exactly. The need for efficiency in developing effective new therapeutics has never been greater. As demands on the global healthcare system increase and treating disease becomes more complex, the research,

More information

ISPE San Diego Chapter Quality by Design and Compliance Meeting

ISPE San Diego Chapter Quality by Design and Compliance Meeting ISPE San Diego Chapter Quality by Design and Compliance Meeting 4:30-7:45 pm Sponsored by: CRB Location: CRB 3207 Grey Hawk Court, Suite 150 Carlsbad, CA 92010 Program Managers: Rod Freeman, Global Process

More information

Bedford County Technical Center, Lampire Biological Laboratories, Allegany College of Maryland & Bedford County Development Association Partners in

Bedford County Technical Center, Lampire Biological Laboratories, Allegany College of Maryland & Bedford County Development Association Partners in Bedford County Technical Center, Lampire Biological Laboratories, Allegany College of Maryland & Bedford County Development Association Partners in Educational Advancement, Partners in Workforce Development

More information

Risk-Based Environmental Monitoring. Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI

Risk-Based Environmental Monitoring. Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI Risk-Based Environmental Monitoring Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI Presenter Marsha Stabler Hardiman Over 20 years experience in the

More information

Contamination Control

Contamination Control This course will provide practice-oriented guidance and includes practical workshops and case studies Contamination Control Microbial Contamination Sources/Preventive Measures/ Disinfection Management

More information

GMP Facility Design with Good Engineering Practice

GMP Facility Design with Good Engineering Practice National University of Singapore Academy of GxP Excellence (NUSAGE) and PharmEng Technology Presents GMP Facility Design with Good Engineering Practice Part of the Pharmaceutical and Biotechnology Training

More information

BEHAVIOUR EXPERIENCE MEDIA FILL QUALIFICATION TRAINING MONITORING GOWNING PERSONAL ATTRIBUTES QUALIFICATION

BEHAVIOUR EXPERIENCE MEDIA FILL QUALIFICATION TRAINING MONITORING GOWNING PERSONAL ATTRIBUTES QUALIFICATION QUALIFICATION OF ASEPTIC OPERATORS Jaap Koster EXPERIENCE BEHAVIOUR MEDIA FILL QUALIFICATION TRAINING MONITORING GOWNING QUALIFICATION PERSONAL ATTRIBUTES 2 TRAINING GENERAL PRINCIPLES Personnel should

More information

UNITED THERAPEUTICS CORP

UNITED THERAPEUTICS CORP UNITED THERAPEUTICS CORP FORM 8-K (Current report filing) Filed 11/13/14 for the Period Ending 11/11/14 Address 1040 SPRING ST SILVER SPRING, MD 20910 Telephone 3016089292 CIK 0001082554 Symbol UTHR SIC

More information

2015 FOYA Award for facility integration Multipurpose Biologics and Vaccines Production Facility. IDT Biologika 2015 FOYA Award Facility Integration

2015 FOYA Award for facility integration Multipurpose Biologics and Vaccines Production Facility. IDT Biologika 2015 FOYA Award Facility Integration 2015 FOYA Award for facility integration Multipurpose Biologics and Vaccines Production Facility 1 Agenda ABOUT IDT BIOLOGIKA FACILITY HIGHLIGHTS AND INNOVATIVE FEATURES BUILDING CONCEPT AND PROJECT OVERVIEW

More information

Cleanrooms and associated controlled environments. Part 1: Classification of air cleanliness by particle concentration

Cleanrooms and associated controlled environments. Part 1: Classification of air cleanliness by particle concentration INTERNATIONAL STANDARD ISO 14644-1 Second edition 2015-12-15 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration Salles propres et environnements

More information

Plant Solutions for Next Generation Biopharmaceuticals and Regenerative Medicine

Plant Solutions for Next Generation Biopharmaceuticals and Regenerative Medicine 676 Hitachi Review Vol. 64 (2016), No. 10 Featured Articles Plant Solutions for Next Generation Biopharmaceuticals and Regenerative Medicine Haruo Suzuki Yukio Fukushima Tadatoshi Iwabuchi Yoshinori Momota

More information

2014 Report: biotechnologies in the Italian pharmaceutical sector

2014 Report: biotechnologies in the Italian pharmaceutical sector 2014 Report: biotechnologies in the Italian pharmaceutical sector In collaboration with Assobiotec Executive summary Executive summary Executive summary Biotechnologies have always influenced all spheres

More information

Graduate School of Excellence Exzellenz-Graduiertenschule

Graduate School of Excellence Exzellenz-Graduiertenschule Jena School for Microbial Communication Graduate School of Excellence Exzellenz-Graduiertenschule Microbial Communication Talking Microbes? Microorganisms are present everywhere. They are often considered

More information

Pharma & Biotech processes: global turnkey solutions

Pharma & Biotech processes: global turnkey solutions Pharma & Biotech processes: global turnkey solutions 02 Our mission: to design and build turnkey process solutions AS A LEADING-EDGE INDUSTRIAL INTEGRA- TOR, BOCCARD DESIGNS AND BUILDS UNIQUE PHARMACEUTICAL

More information

We invite you to join the community of life science industry supporters of Keystone Symposia. What your support makes possible:

We invite you to join the community of life science industry supporters of Keystone Symposia. What your support makes possible: What your support makes possible: Catalyzing Collaborations Keystone Symposia Support and Recognition Opportunities Accelerating Discoveries Preparing and Positioning the Next Generation of Leading Life

More information

Manufacturing. Environmental Monitoring Particle Counts Are Easy B IOP ROCESSTECHNICAL. Scott E. Mackler

Manufacturing. Environmental Monitoring Particle Counts Are Easy B IOP ROCESSTECHNICAL. Scott E. Mackler B IOP ROCESSTECHNICAL Environmental Monitoring Particle Counts Are Easy Scott E. Mackler Manufacturing pharmaceutical and biotechnology products requires that the appropriate level of quality be designed

More information

The Biotechnology Program at Montgomery College. Presented by Dr. Sanjay Rai Interim Vice President and Provost Germantown Campus Montgomery College

The Biotechnology Program at Montgomery College. Presented by Dr. Sanjay Rai Interim Vice President and Provost Germantown Campus Montgomery College The Biotechnology Program at Montgomery College Presented by Dr. Sanjay Rai Interim Vice President and Provost Germantown Campus Montgomery College Biotechnology Meeting the demand for a skilled workforce

More information

tdodds@jeffyuen.com 714 282-1014 Jeff Yuen and Associates, Inc. PO Box 6026 Orange, CA 92863 Terri Dodds CAPT. (RET) TERRI L.

tdodds@jeffyuen.com 714 282-1014 Jeff Yuen and Associates, Inc. PO Box 6026 Orange, CA 92863 Terri Dodds CAPT. (RET) TERRI L. SKILLS/SPECIAL QUALIFICATIONS: Regulatory Expertise: Technical Expertise: CAPT. (RET) TERRI L. DODDS - BSN, RN Former Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals,

More information

Particle testing in cleanroom high-pressure gas lines to ISO 14644 made easy with the MET ONE 3400 gas calibrations

Particle testing in cleanroom high-pressure gas lines to ISO 14644 made easy with the MET ONE 3400 gas calibrations Particle testing in cleanroom high-pressure gas lines to ISO 14644 made easy with the MET ONE 3400 gas calibrations B e c k m a n C o u l t e r L i f e S c i e n c e s 2 5 0 S. K r a e m e r B o u l e

More information

Is a Career in the. Pharmaceutical. Check out our online Student Center to find out more: www.aaps.org/forstudents

Is a Career in the. Pharmaceutical. Check out our online Student Center to find out more: www.aaps.org/forstudents Is a Career in the Pharmaceutical Sciences Right for Me? Check out our online Student Center to find out more: www.aaps.org/forstudents How Do I Know If a Career in the Pharmaceutical Sciences is Right

More information

MINISTRY OF HIGHER EDUCATION UNIVERSITY OF HAIL COLLEGE OF PHARMACY

MINISTRY OF HIGHER EDUCATION UNIVERSITY OF HAIL COLLEGE OF PHARMACY MINISTRY OF HIGHER EDUCATION UNIVERSITY OF HAIL COLLEGE OF PHARMACY Academic Reference Standards of Pharm.-D Program College of Pharmacy-University of Hail May The Major shift in the health-care system

More information

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualification and Validation)

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualification and Validation) Global CompliancePanel Knowledge, a Way Forward 2-day In-person Seminar: Process Validation Guidance Requirements (FDA and EU Annex 15: Qualification and Validation) Los Angeles, CA July 28th & 29th, 2016

More information

Process filtration Adding value to your business

Process filtration Adding value to your business Process filtration Adding value to your business Parker domnick hunter specializes in the manufacture and supply of high quality products for the clarification, stabilization and sterilization of liquids

More information

Guidelines for drafting a Site Master File (SMF)

Guidelines for drafting a Site Master File (SMF) Guidelines for drafting a Site Master File (SMF) A Site Master File for each manufacturing site listed in a product dossier, must be submitted to World Health Organization, HTP/EDM/QSM, 20 Ave Appia, 1211

More information

THE BIOTECH & PHARMACEUTICAL INDUSTRY

THE BIOTECH & PHARMACEUTICAL INDUSTRY THE BIOTECH & PHARMACEUTICAL INDUSTRY ESSENTIAL CAREERS INFORMATION CALUM LECKIE KATIE BISARO CAREERS CONSULTANTS What we will cover Sector overview Types of role Graduate recruitment trends and issues

More information

PG Certificate / PG Diploma / MSc in Clinical Pharmacy

PG Certificate / PG Diploma / MSc in Clinical Pharmacy PG Certificate / PG Diploma / MSc in Clinical Pharmacy Programme Information September 2014 Entry School of Pharmacy Queen s University Belfast Queen s University Belfast - Clinical Pharmacy programme

More information

CALCET Company California Consulting Engineering & Technology 14895 E14th St. Ste 340, San Leandro, CA 94578 USA www.calcet.com

CALCET Company California Consulting Engineering & Technology 14895 E14th St. Ste 340, San Leandro, CA 94578 USA www.calcet.com CALCET Company California Consulting Engineering & Technology 14895 E14th St. Ste 340, San Leandro, CA 94578 USA www.calcet.com ENGINEERING A PIVOTAL ROLE IN BIOTECHNOLOGY AND PHARMACEUTICAL INDUSTRIES

More information

GUIDELINES TO THE OHIO DEPARTMENT OF HEALTH S CERTIFICATION IN FOOD PROTECTION

GUIDELINES TO THE OHIO DEPARTMENT OF HEALTH S CERTIFICATION IN FOOD PROTECTION GUIDELINES TO THE OHIO DEPARTMENT OF HEALTH S ERTIFIATION IN FOOD PROTETION To protect and improve the health of all Ohioans 9/98 ertification in Food Protection Guidelines Page 1 of 14 TABLE OF ONTENTS

More information

The Ontario Health Care Labour Market: Opportunities for Internationally Trained Physicians

The Ontario Health Care Labour Market: Opportunities for Internationally Trained Physicians The Ontario Health Care Labour Market: Opportunities for Internationally Trained Physicians Prepared for; May 3, 2005 Prepared by Libbey Haughian Associates in cooperation with: SISO Hamilton: Project

More information

BIOTECH MANUFACTURING SOLUTIONS 4 YOUR SUCCESS. a Novartis company

BIOTECH MANUFACTURING SOLUTIONS 4 YOUR SUCCESS. a Novartis company a Novartis company BIOTECH MANUFACTURING Sandoz GmbH Biotech Cooperations 6250 Kundl Austria Biochemiestrasse10 Phone +43 (0)5338 200 2609 Fax +43 (0)5338 200 442 biotech.cooperations@sandoz.com www.sandoz.com

More information

LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals

LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals MAbLaunch TM is a joint bioproduction platform combining LFB Biomanufacturing (LFB

More information

ENVIRONMENTAL, HEALTH AND SAFETY PERSONNEL MANAGEMENT LEVELING GUIDE

ENVIRONMENTAL, HEALTH AND SAFETY PERSONNEL MANAGEMENT LEVELING GUIDE ENVIRONMENTAL, HEALTH AND SAFETY PERSONNEL MANAGEMENT LEVELING GUIDE Levels Job Codes Scope of Position Top Environmental Affairs Executive (Corporate) 1000 The most senior Environmental, Health and Safety

More information

School of Pharmacy TEMPLE UNIVERSITY

School of Pharmacy TEMPLE UNIVERSITY School of Pharmacy TEMPLE UNIVERSITY Regulatory Affairs and Quality Assurance Graduate Program Te mple Unive rsity School of Pharmacy Re gulatory Affairs and Quality Assurance Graduate Program 4 25 Comme

More information

Health Care Compliance One of Today s Fastest Growing Industries

Health Care Compliance One of Today s Fastest Growing Industries Health Care Compliance One of Today s Fastest Growing Industries Become a certified health care compliance professional Acquire knowledge and expertise to enhance your current job performance Program designed

More information

S-GE Impulse: Life Science, April 14, 2015, Messe Basel GLOBAL BIOTECH

S-GE Impulse: Life Science, April 14, 2015, Messe Basel GLOBAL BIOTECH S-GE Impulse: Life Science, April 14, 2015, Messe Basel GLOBAL BIOTECH OFFICIAL PROGRAM PREMIUM PARTNER Overview Most biotech companies seek an international strategy and orientation, either for their

More information

Design, Operation and Management of GTP/GMP Cell Engineering Facilities

Design, Operation and Management of GTP/GMP Cell Engineering Facilities Design, Operation and Management of GTP/GMP Cell Engineering Facilities Scott R. Burger, MD Advanced Cell & Gene Therapy BFDA 2007 International Symposium on Regulation of Human Cell and Tissue- Based

More information

Current Good Manufacturing Practice for PET Drugs - CGMP 21 CFR 212

Current Good Manufacturing Practice for PET Drugs - CGMP 21 CFR 212 Current Good Manufacturing Practice for PET Drugs - CGMP 21 CFR 212 CDER Office of Regulatory Policy Jane Axelrad, JD CDER Office of Compliance Brenda Uratani, Ph.D. CDER ONDQA Ravindra Kasliwal, Ph.D.

More information

Air and Water Balancing - Sound and Vibration Testing - Cleanroom Services - Building Commissioning Building Envelope Testing Thermal Imaging

Air and Water Balancing - Sound and Vibration Testing - Cleanroom Services - Building Commissioning Building Envelope Testing Thermal Imaging NEUDORFER ENGINEERS, INC. provides our customer with unbiased, professional, performance testing of Cleanrooms. We are committed to providing you, our customer, with value-added expertise in an effort

More information

Salary Survey 2014. Domestic, International Salary Survey and Country Cost Analysis

Salary Survey 2014. Domestic, International Salary Survey and Country Cost Analysis Salary Survey 2014 Domestic, International Salary Survey and Country Cost Analysis Disclaimer: This salary guides contained herewith have been constructed to represent average salaries across a range of

More information

Anthem College Bryman School 9215 North Black Canyon Highway Phoenix, Arizona 85021

Anthem College Bryman School 9215 North Black Canyon Highway Phoenix, Arizona 85021 Anthem College Bryman School 9215 North Black Canyon Highway Phoenix, Arizona 85021 Addendum to the March 5, 2014 Catalog. This bulletin is an integral part of the College s Academic Catalog. The purpose

More information

Accrediting and Standardizing Pharmacy Technician Training. Paul Sabatini, CPhT, B.S. CPTA Board of Directors. Programs

Accrediting and Standardizing Pharmacy Technician Training. Paul Sabatini, CPhT, B.S. CPTA Board of Directors. Programs Accrediting and Standardizing Pharmacy Technician Training Paul Sabatini, CPhT, B.S. CPTA Board of Directors Programs Disclosure Paul Sabatini reports no significant or relevant relationships or other

More information

Faculty Development in International Entrepreneurship (FDIE) June 2-5, 2008 Denver, Colorado

Faculty Development in International Entrepreneurship (FDIE) June 2-5, 2008 Denver, Colorado Faculty Development in International Entrepreneurship (FDIE) June 2-5, 2008 Denver, Colorado Sponsored by the U.S. Department of Education and the Center for International Business Education and Research

More information

UCF, College of Medicine BS Biotechnology MS Biotechnology/MBA Professional Science Masters Program in Biotechnology/MBA

UCF, College of Medicine BS Biotechnology MS Biotechnology/MBA Professional Science Masters Program in Biotechnology/MBA UCF, College of Medicine BS Biotechnology MS Biotechnology/MBA Professional Science Masters Program in Biotechnology/MBA Dr. Henry Daniell Pegasus Professor & University Board of Trustee Chair Dept. Mol.

More information

Background: Pathways for the Master s Degree (Thesis and Non Thesis)

Background: Pathways for the Master s Degree (Thesis and Non Thesis) Differences between the Non Thesis (Project) and Thesis Options for the M.S. in Pharmacy with an emphasis in BioPharma Regulatory Affairs Offered by the University of Georgia College of Pharmacy Background:

More information

2006-2167: PREPARING BIOMEDICAL ENGINEERS FOR CAREER ADVANCEMENT: THE HEALTHCARE TECHNOLOGIES MANAGEMENT PROGRAM

2006-2167: PREPARING BIOMEDICAL ENGINEERS FOR CAREER ADVANCEMENT: THE HEALTHCARE TECHNOLOGIES MANAGEMENT PROGRAM 2006-2167: PREPARING BIOMEDICAL ENGINEERS FOR CAREER ADVANCEMENT: THE HEALTHCARE TECHNOLOGIES MANAGEMENT PROGRAM Jay Goldberg, Marquette University Dr. Goldberg is the Director of the Healthcare Technologies

More information