A Risk Based Approach to Computer Systems Validation
Label
Label
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
Description
This intensive, 2-day course is designed to provide an
overview of the various aspects of computer validation
including best practices, US and International regulations, and
Industry expectations. It addresses the rules, tools and
techniques to develop and provide the basis for compliance
and implementation for a single system or a company-wide
program and process.
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.