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CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training/In Conjunction with Medical Device Summit
July 29, 2010 at 11:00 a.m.–12:30 p.m. (ET)
ho Should Attend
This session will benefit professionals working within the medical device and pharmaceutical industries who want to learn how to evaluate risk as part of a validation project. It will be especially valuable to:
• Validation professionals
• Managers
• QA staff
• Software developers
• Medical device design personnel
• Auditors Description
This 90-minute accredited online training course is designed to introduce the concept of Risk/Hazard Assessment. It addresses when to do an assessment, what tools are available, what the FDA expects and how it can save you time, money and resources. By understanding Risk Assessment participants will be able to use the techniques and tools to: prioritize and plan validation projects and submissions, plan testing, and define “what is enough “and when they are “done.”
Module 1: Define computer system validation:
• FDA's definition
• Tasks
Module 2: FDA Guidelines:
• Least burdensome approach
• The role of Risk Assessment
• When is Risk Assessment required
Module 3: Tools and Techniques:
• ISO14971
• FMEA
• Fault Tree
• HACCP
• Root Cause-5 Why's
Question and Answer Session
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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, Vice President, Quality Assurance, inVentiv Clinical Solutions
Philip Sax has worked with regulated companies throughout the world to develop and implement compliance programs, strategies, validation, training and FDA representation. Since 1987, he has trained more than 4000 professionals and has participated in more than 500 compliance and regulatory projects.
Mr. Sax holds a Master of Government Administration from the Wharton School at the University of Pennsylvania, A Bachelor of Arts from Rutgers University and is a Candidate for a PhD from California Coast University. He has served as a Member of the Management faculty at the University of Phoenix, and on the management, business, political science and computer science faculties at Rutgers and La Salle Universities.
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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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