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The Center for Professional Advancement, 90 Minute Accredited Online Training
February 24, 2009
Who Should Attend
This course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industries including:
• Engineers
• Quality Assurance
• Quality Control
• Facilities Managers
• Utility Managers
• Validation Professional
• Regulatory Affairs
Anyone responsible for designing, managing, sampling, operating, validating or regulatory affairs of compendial water systems will find this training valuable. Participants ranging from those with little to no experience with water systems, to those with several years of experience will benefit. Description
Water is the single largest ingredient used in biopharmaceutical manufacturing, and permeates every aspect of biopharmaceutical manufacturing. The uses of water, and steam derived from water, constitutes a major operational and quality issue in the industry on a worldwide basis. As such, water is governed by specific requirements for quality and use. This 90-minute accredited training session will review U.S. and international validation requirements, and define basic validation and start up protocols.
Module 1:
• Water System Validation Regulatory Requirements
• Validation Strategies
Module 2:
• IQ/OQ/PQ for Water Systems
• Water System Testing in PQ
Module 3:
• International Differences
• Design Qualification
• Start Up Protocols and Issues
Question and Answer Session
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Dr. Hu Fleming is Global Director, Hatch Water, an international engineering/consultant firm with expertise in water systems.
Dr. Fleming received his M.S. and PhD degrees in chemical engineering from Cornell University, and is a graduate of Harvard's Executive Management Program. Dr. Fleming is an authority in water and utilities, with nearly 30 years of experience. He has authored more than 60 publications, eight book chapters, and 16 patents in various aspects of water management. He has also authored or co-authored several books, including the Handbook of Membrane Technology.
Dr. Fleming has held Adjunct Professor positions at Parenteral Drug Association Training Institute, Stephens Institute of Technology, and Worcester Polytechnic Institute. He is past chairman of the International Congress on Membranes and Membrane Processes, and is a member of several international panels on water, including the Task Force on Water for WHO, EPA's Clean Water Act Advisory Group, ASTM D-19 Committee on Water Standards, and the Purified Water Working Group of the Parenteral Drug Association. Dr. Fleming has been a consultant to FDA on water issues, as well as to MCA, and to PharmEuropa, as well as to numerous pharmaceutical manufacturers.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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salbers@cfpa.com
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