10:00 AM - 02:00 PM
Day 1

• Identifying “GxP” Systems
• Current state of CSV approach based on FDA requirements
• Agile approach to System Development Life Cycle (SDLC)
• Pros and Cons of an Agile vs. Waterfall approach
• Cloud computing and Software as a Service (SaaS) systems
• Agile continuous validation approach
• Policies and procedures needed to support your validation process
• Q&A

10:00 AM - 02:00 PM
Day 2

• CSA Gap Assessment
• Keys to a Successful CSA Implementation
• Documentation using a Waterfall or Agile approach
• Implementing CSA Across the organization – Avoiding disorientation
• Applicability of CSA Guidance to Data Integrity
• IT Supplier Assessments While Adopting CSA Principles
• Risk Assessment to optimize your validation approach
• Q&A