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Process Validation for the Pharmaceutical and Medical Device Industries

 
  June 06, 2011  
     
 
CfPA - The Center for Professional Advancement, New Brunswick, NJ
September 12-13, 2011


Who Should Attend
This course is intended for professionals involved in the pharmaceutical and related industries, including, but not limited to:

  • Quality Assurance 
  • Quality Control
  • Production 
  • Regulatory
  • Engineering 
  • Research and Development, and software
  • Process Design and Development

Description
Validation of manufacturing processes in the cGMP environment is recognized by the medical manufacturing industries and by the regulatory agencies in the U.S., E.U. and Japan. This course will give the attendee an overview and understanding of the validation process, how to organize it and carry out process validations, key areas to look for during an audit, and assist managers in overall planning.

Various approaches to validation will be discussed with actual examples of successes and failures of industry validation experiences.

Participants are invited to bring examples of their own validation issues to be discussed during the case studies session.

 
 
Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: William G. Marshall; President, William G. Marshall and Associates

William G. Marshall, President of William G. Marshall and Associates, has over twenty years experience in the Pharmaceutical and Medical Device Manufacturing Environment. Mr. Marshall has held Director level and Chief Operating Officer positions with large multinational corporations as well as start-up ventures. He has been the Director of a major reference laboratory and has been active in clean room design and validation.

Mr. Marshall is currently a consultant to most of the major multinational Drug and Device Manufacturers as well as venture start-ups. He has served as third party consultant for several companies in consent decree and consulted for the FDA.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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