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Pharmaceutical Water and the International Regulatory Environment

 
  January 27, 2014  
     
 
CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
March 4, 2014 at 11:00 a.m.–12:30 p.m. (ET)


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 
  • Utility Managers
  • Quality Assurance and Control 
  • Validation Professionals
  • Facilities Managers 
  • Regulatory Affairs Staff in the Biopharmaceutical 
    Industry

Description
This course will be available On Demand: March 5, 2014

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.

 
 
Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: 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.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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