Reduce COTS software validation using the 10 step risk based approach 2013

Key Topics

• Efficiently create validation documentation
• Increase corporate productivity and individual workforce member productivity
• Proven techniques that reduce software costs and implementation times
• Documents the FDA expects to audit
• Make documentation more manageable and understandable
• Decrease resource requirements
• How to implement a computer system to gain maximum productivity
• Avoid 483s and Warning Letters
• How to link requirements, specifications, risk management, and testing
• Use resources effectively to perform effective validation while avoiding doing too much
• Based on: "Risk-Based Software Validation – Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006)
• Document a computer system validation project using easy to understand fill-in-the-blank templates

Who should Attend

IT, Computer System users, Managers, QA and Executives.