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Computer System Validation: Rules and Tools

 
  January 15, 2020  
     
 
CfPA-The Center for Professional Advancement, Edison, NJ or Virtually
May 18-19, 2020


Who Should Attend?
This course is intended for professionals in the pharmaceutical and other life science industries working in all facets of computer systems. The course addresses the responsibilities, roles, tasks and acceptable techniques associated with the following personnel:
  • System Users
  • Quality Assurance and Control Staff
  • Project Managers
  • System Developers, Designers and Integrators
  • IT Professionals
  • System Vendors
  • Regulatory Staff
  • Auditors

Professionals who manage staff in any of these areas would also benefit from this course by gaining a better understanding of the current regulations and most recent issues.

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. The course will review most current compliance issues for the FDA. Additionally, students will participate in an in class computer validation case study.
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   Philip E. Sax, Adjunct Assistant Professor, Temple University

Phil Sax was an early thought leader for CSV. A Founder and President of Weinberg Spelton and Sax, a Computer System Validation Consultancy, he has been involved in hundreds of successful validation projects. He has trained more than 1000 professionals, including FDA staff and has served as Vice President and Chief Regulatory and Quality Officer for 3 international companies. Phil has consulted and worked in 19 countries throughout North American, Europe, Asia and the Middle East. Phil testified to the US House of Representatives about Computer System Validation issues. Since 2014 Phil as served as an Adjunct Assistant professor in the Masters of regulatory Affairs and Quality Assurance Program of the pharmacy School at Temple University. He has developed and directed courses in validation, Good Clinical Practices and Drug Development.
 
Deadline for Abstracts: N/A
 
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
 
 
   
 
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