10:00 AM - 01:00 PM
Session 1

- Learn how to identify “GxP” Systems
- Learn about FDA’s current thinking about technology and software development, and how this will impact industry
- Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements
- Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation
- Learn about cloud services and cloud service providers to optimize your experience
- Learn ways to validate in the cloud without compromising quality or compliance
- Learn the pros and cons of an agile vs. waterfall approach
- We will discuss cloud computing and Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), and Platform-as-a-Service (PaaS) systems that can be embraced and validated effectively
- Discuss the best practices for documenting computer system validation efforts, whether using a waterfall or agile approach, including requirements, design, development, testing and operational maintenance procedures, including ways to improve efficiency and effectiveness of managing related documentation

01:00 PM - 04:00 PM
Session 2

- Understand the best approach to Installation Qualification (IQ) testing when the system components are not on premise, but in the cloud
- Understand how to maintain a system in a validated state through the system’s entire life cycle in a more cost-effective manner, applying an Agile continuous validation approach
- Learn how to assure the integrity of data that supports GxP work, despite changes and advances in new technology
- Discuss the importance of “GxP” documentation that complies with FDA requirements
- Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
- Know the regulatory influences that lead to FDA’s current thinking at any given time
- Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle