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A Risk Based Approach to Computer Systems Validation

 
  January 24, 2019  
     
 
CfPA-The Center for Professional Advancement, New Brunswick, NJ or Virtually
June 17-18, 2019


Who Should Attend?
The course is intended for system users, developers, quality assurance, quality auditors and regulatory professionals. It is designed to address their responsibilities, roles, tasks and techniques. 

The program will benefit:
  • System Users
  • Quality Assurance and Control Staff
  • Project Managers
  • System Developers, Designers and Integrators
  • IT Professionals
  • System Vendors
  • Regulatory Staff

Course Description
This intensive, 2-day course is designed to provide an overview of the various aspects of computer validation including best practices, US and International regulations, and Industry expectations. It addresses the rules, tools and techniques to develop and provide the basis for compliance and implementation for a single system or a company-wide program and process.

The emphasis is on the most recent concepts and practices including: risk assessment, vendor controls, electronic records and signatures, common problems, the Validation Project, Validation Planning, Validation Process, Testing and more. It will answer the key question: “What is enough/When am I done?”

You will have the opportunity to ask specific question and participate in class room exercises as time allows.
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   Philip E. Sax, Adjunct Assistant Professor, Temple University

Philip E. Sax has more than 30 years’ experience in FDA regulated industries. He has served as the Chief Regulatory and Quality Officer for three companies and has consulted extensively to US and internationals companies. Currently Mr. Sax is an Adjunct Assistant Professor in Temple University’s Master of Regulatory Affairs and Quality Assurance Program and he provides consulting support to leading regulated companies.

Mr. Sax has a BA in Political Science and a Master of Government Administration from the Fels Center of Government, Wharton School, University of Pennsylvania.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
 
 
   
 
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