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Active Pharmaceutical Ingredient (API) and Drug Product Specifications

 
  July 05, 2012  
     
 
Center for Professional Innovation & Education, Inc., Berlin, Germany
Dec. 12 – 14, 2012


This comprehensive three-day course is valuable to R&D personnel involved with researching synthetic routes, scaling up and manufacturing Active Pharmaceutical Ingredients (APIs).  Course content will provide attendees with a comprehensive understanding of operations involved in the manufacture and testing of APIs for non-clinical and clinical use. The varied methods used in determining specifications for Active Pharmaceutical Ingredients (APIs), raw materials, intermediates, drug products, excipients and placebos will be discussed.  Specific attention is given to FDA guidance and ICH regulatory guidelines.  Upon completion of this course, attendees will have a clear understanding of the many factors implicit in chemical route selection and specifications to meet regulatory agency expectations.
 
 
Organized by: Center for Professional Innovation & Education
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=011&source=hummolgen
E-mail: info@cfpie.com
 
   
 
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