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Introduction to Validation Principles, Practices and Requirements

 
  February 12, 2019  
     
 
CfPA-The Center for Professional Advancement, New Brunswick, NJ or Virtually
August 7-8, 2019


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.

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 classifications 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.
 
 
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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