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Introduction to Validation Principles, Practices and Requirements

 
  July 07, 2017  
     
 
CfPA-The Center for Professional Advancement, New Brunswick, NJ
November 2-3, 2017


Who Should Attend?
This course is designed for professionals in the Pharmaceutical and Medical Device industries who have validation responsibilities, who have a need to understand validation requirements, who desire to conduct and manage validation functions and who have a desire to understand validation types and requirements.

The course will be especially beneficial to professionals in the Quality , Regulatory, Engineering an Auditing areas.

RAPS - Regulatory Affairs Professional Society 
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion. 

Course Description
FDA regulated industries utilize several types of validation to help insure the quality of their products and to comply with FDA and international regulations and requirements.

This 2-day, accredited training course provides an overview and introduction to Validation principles and requirements. Discussed in this program are:
– Process validation
– Computer System Validation
– Cleaning validation
– Methods validation
– Qualifications
– Validation Project Management

The course is designed to provide a basic understanding of 4 classification of validation that are generally recognized throughout the industry and by regulators. The program provides an effective and efficient transition to more advanced and specialized validation programs and responsibilities. To further enhance the lecture material, case studies discussions, protocol review and interactive exercise will be employed.
 

Virtual Attendee Training Option

This course offers the virtual option.

Can't attend the live, in person course? Our remote option provides you with a complete online live experience.
Select "Virtual Attendee" when registering. For more information on Virtual Attendee Training Click Here
 
 
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 Phil 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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