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CfPA-The Center for Professional Advancement, 90 Minute Accredited Online Training
June 16, 2014 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This session will benefit anyone responsible for or involved in regulatory aspects of designing, managing, sampling, operating, or the validating of compendial water systems. Participants ranging from those with little to no experience with water systems to those with several years of experience will find the session very valuable.
It is intended for:
• Engineers
• Utility Managers
• Facilities Managers
• Validation Professionals
• Quality Assurance and Control
• Regulatory Affairs Staff in the Biopharmaceutical Industry Description
This course will be available On Demand: May 30, 2014
This accredited online training course will focus on the elements, responsibilities and measurements of the pharmaceutical Quality System, paying special attention to components of the system that are often problematic and focused on by regulators. The course will identify common tools that can be used to solve problems and discuss eliminating manufacturing non-compliance. With water being the single largest ingredient used in biopharmaceutical manufacturing, the use of it constitutes major operational and quality issues in the industry on a global level. Water is governed by specific requirements for quality and use. This course will review options for meeting U.S. and all pertinent international standards.
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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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Dr. Hu Fleming, Consultant to the Pharmaceutical Industry
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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sberg@cfpa.com
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