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Process Validation for Drugs and Biologics

 
  October 15, 2012  
     
 
Center for Professional Innovation & Education, Inc., King of Prussia, PA
Feb 11 & 12, 2013



Process validation is not a course invented by regulators and pushed onto a company by QA staff.  Instead, it is a legal requirement in the pharmaceutical industry.  The concept of process validation is recognition that quality cannot be tested into the product and must be designed into the process/product to reduce the risk of non-conformances during/after manufacturing.
 
This course provides practical guidance on compliance with the requirements of process validation that lead to risk-based, reasonable and supportable informed decisions.  Compliance with the requirement for process validation must go hand in hand with sound science for the proper evolution of critical processes.
 
The course includes process validation examples from pharmaceutical, biologic and biopharmaceutical manufacturing processes. This includes the manufacturing of the API and the finished drug products.
 
 
Organized by: Center for Professional Innovation & Education, Inc.
Invited Speakers: Contact info@cfpie.com for a list of course instructors
 
Deadline for Abstracts: n/a
 
Registration: http://www.cfpie.com/showitem.aspx?productid=049&source=hummolgen
E-mail: info@cfpie.com
 
   
 
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