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The Center for Professional Advancement, New Brunswick, NJ
March 26-28, 2008
Who Should Attend
This course is designed for both users and developers of FDA regulated systems, especially personnel involved in- Conducting Clinical Studies
- Laboratory Analysis
- Quality Assurance
- Product Development
- Regulatory Submissions
- Information Systems
Those developing, acquiring, using, modifying, auditing, designing, and marketing systems and devices that support FDA regulated studies, submissions, projects and products will also benefit.Description
This course is designed to provide the basics of computer system validation. Utilizing lectures, discussions, hands on exercises, the class will address the rules, tools and techniques needed to develop, manage, and conduct a validation process and project. The program focuses on thebest validation practices utilizing, Risk assessment, PAT, GAMP 4 and more. Included in this comprehensive course is:- Validation testing, The Validation Plan, SOPs
- System Life Cycle, Hazard Assessment
- Validation Requirements of Predicate Rules including: cGMPs, GLPs, QSRs and GCPs
- ERES 21 CFR Part11, Electronic Submissions
- Disaster Planning and Business continuation, IQ, OQ, PQ
- System Security, Training Requirements, Traceability
- Source Code Vendor Review
- COTs and Shrink Wrapped Systems
- GAMP 4 and PAT
- Sarbanes Oxley
- FDA Guidance for Industry-Computerized Systems Used in Clinical Trials
The course workbook is designed to support you in class and to be a detailed and complete validation reference guide.
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Philip E. Sax, Principal Consultant and President, FDA Compliance Solutions
Philip E. Sax is the Principal Consultant and President of FDA Compliance Solutions of Cherry Hill, New Jersey.
Mr. Sax has worked with regulated companies throughout the world to develop and implement compliance programs, develop strategies, manage and conduct validation projects, assess risks, develop plans and provide 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 and Political Science faculty at Rutgers University, and has lectured at the Universities Phoenix, La Salle, De Vry, Temple and Drexel.
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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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info@cfpa.com
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