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Cost Contained Regulatory Compliance for the Drug, Biologics and Medical Device Industries

 
  December 01, 2009  
     
 
The Center for Professional Innovation & Education, Malvern, PA
February 22 & 23, 2010


Who Should Attend

This is a practical, hands-on course designed to provide Pharmaceutical, Biopharmaceutical, and Biologics professionals with the information and tools needed to manage regulatory compliance in a cost controlled and contained manner.  The course is ideal for managers, directors, and vice presidents of Regulatory Affairs and Compliance who are concerned about budgetary issues.




Learning Objectives

The course is designed to meet the objectives of cost containment in regulatory compliance.  Upon completion of the course you will:
  • Be familiar with six (6) major strategies for cost containment in regulatory compliance, submissions, and regulatory affairs
  • Have an opportunity to test out those strategies in case study analyses
  • Have resources for reference and update
  • Be aware of future changes and developments in the FDA that might effect cost contained compliance



Course Description

This course is designed to provide participants with six tested strategies for assuring FDA regulatory compliance while controlling the expenses and costs of regulation.  The strategies (Operational Definitions, Pre-Audits, Quality by Design, Outsourcing, Electronic Submissions, and EMEA Overlap) are explained in a context of assuring compliance with the spirit and letter of FDA regulations while avoiding unnecessary regulatory expenses and tactics. 

Additional benefits of this class include:

  • A complete set of course notes, key guidance documents and tools for managing compliance which will provide each attendee with a blueprint for adopting the strategies covered during the course
  • A chance to actively learn form fellow participants as well as from an instructor who brings 30 years of practical regulatory experience to a lively combination of lecture, discussion, and exercises
 
 
Organized by: Center for Professional Innovation & Education
Invited Speakers: info@cfpie.com
 
Deadline for Abstracts: n/a
 
Registration:

http://www.cfpie.com/showitem.aspx?productid=009&source=hummolgen

E-mail: info@cfpie.com
 
   
 
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