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Introduction to Validation Principles, Practices and Requirements

 
  February 25, 2020  
     
 
CfPA- The Center for Professional Advancement, Edison, NJ
June 15-16. 2020


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

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: knee@cfpa.com
 
 
   
 
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