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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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December 16, 2015 |
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CfPA-The Center for Professional Advancement, New Brunswick, NJ
May 23-24, 2016
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
• Project Managers
• IT Professionals
• Regulatory Staff
• Quality Assurance and Control Staff
• System Developers, Designers and Integrators
• System Vendors Course Description
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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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| Philip E. Sax; Validation Consultant to the Life Science Industry |
Philip E. Sax, validation consultant to the Life Science Industry, is a retired Vice President and Chief Regulatory and Quality Officer for an international medical device company. Currently, Mr. Sax serves as an Adjunct Assistant Professor in Temple University‘s Masters Program in Regulatory Affairs and Quality Assurance and as Director of Computer System Validation Programs for the Center for Professional Advancement. As a founder and CEO of Weinberg Spelton and Sax, he has been in the forefront of validation theory and practice since1987. Mr. Sax has also served on the faculty of Rutgers University. He holds a Bachelor’s degree from Rutgers University and Masters Degree from the Wharton School, University of Pennsylvania.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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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.