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Pharmaceutical Water: Chemistry, System Design and Validation

 
  May 21, 2008  
     
 
The Center for Professional Advancement, An Online Training Format
May 29, 2008 at 11:00 a.m. - 12:30 p.m. (EST–New York time)


Who Should Attend
This course is intended for professionals responsible for designing, managing, sampling or operating compendial water systems, and those involved in these systems’ regulatory aspect. Participants ranging from those with little to no experience with water systems, to those with several years of experience will benefit. It is especially valuable to the following:

  • Engineers
  • Quality Assurance Personnel
  • Quality Control Personnel
  • Utility Managers
  • Facilities Managers
  • Regulatory Affairs Professionals 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, constitute a major operational and quality issue in the industry on a world-wide basis. This 90-minute online training course will provide an overview of pharmaceutical water systems, their requirements and basic operation.

Module 1: Introduction to Water

  • The Chemistry, Physics and Microbiology of Water
  • Measurement of Water Quality
  • Definitions of Water Types

Module 2: Regulatory Standards for Water Design of Water Purification Systems
  • Determination of Water Required for Specific Applications
  • Basic Design Strategies
  • Choice/Integration of Stills
  • Storage of Water
  • Distribution Systems/Strategies
  • Hot vs. Cold vs. Intermittent Hot,Options

Module 3: Operational Considerations
  • Sampling, Control Strategies, Sanitization
  • Validation and Start-up
  • Water Production

 
 
Organized by: The Center for Professional Advancement
Invited Speakers: Dr. Hu Fleming, Sr. Vice-President, 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.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: info@cfpa.com
 
   
 
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