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The Center for Professional Advancement, An Online Training Format
June 3, 2008 at 11:00 a.m. - 12:30 p.m. (EST–New York time)
Who Should Attend
This session will benefit anyone responsible for 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
- Quality Assurance and Control
- Facilities Managers
- Utility Managers
- Validation Professionals
- Regulatory Affairs Staff in the Biopharmaceutical Industry
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 world-wide basis. As such, water is governed by specific requirements for quality and use. This course will review U.S. and all pertinent international standards, as well as options for meeting each.
Module 1: Overview of U.S. and International regulatory environmentWhere water and utility systems fit within the regulatory frameworkRegulatory Standards for Water
– Potable Water Sources and the National Safe Drinking Water Act
– Non-compendial Waters (ASTM, CAP, AAMP, Other)
Module 2: U.S. Pharmacopoeial Waters (USP Purified, Water For Injection, Other)Alert vs. Action LimitsCurrent Changes in USP Requirements
Module 3: International Standards (EP, JP, Canadian and others)Harmonization Strategies between standardsEvolving changes in water standardsQuestion & Answer
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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; Senior Vice-President of O'Brien & Gere
Dr. Hu Fleming is Sr. Vice-President of O'Brien & Gere, an international engineering/ consultant firm involved with water systems. Dr. Fleming received his M.S. and PhD degrees in chemical engineering from Cornell Univerity, and is a graduate of Harvard's Executive Management Program. Hu 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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info@cfpa.com
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