Risk-Based Approaches for FDA Regulated Complex Systems
- Philadelphia, PA
Join us for the IVT’s 17th Annual Computer and Software Validation to ensure you implement the most current, compliant procedural trends in an ever-changing technology environment.
Are you up-to-date with the most current CSV regulations and processes?
With the strong regulatory focus from FDA and all other global authorities on data integrity, mobile medical devices, software apps, and cloud computing, it has never been more critical to understand up-to-the-minute regulations, trends and procedures involved with implementing CSV enterprise-wide.
This is industry’s “must-attend” event for CSV validation, IT, engineering and QA professionals who are responsible for implementing and maintaining a best-in-class program.
Collaborate with Your Peers Working in the Validation Environment to:
- Comply with data integrity, cloud computing and mobile device apps regulations
- Implement and maintain a risk-based program company-wide
- Qualify cloud computing environments
- Validate excel spreadsheets
- Qualify network infrastructures
- Conduct a gap analysis of your CSV program
25 PLENARY AND EXPANDED SESSIONS
- Qualification of Cloud Infrastructures and Vendor On-Boarding Processes
- Securing and Validating Excel Spreadsheets
- Network Infrastructure Qualification
- Data Migration and Verification
- Validation of Mobile Devices and Software Applications
- Development of a Risk-based Impact Assessment
- Reducing Costs while Maximizing Productivity
- Identifying and Overcoming Data Integrity Challenges
- Creation of a Global CSV Gap Analysis Program — Track, Report and Remediate
- Implementation of a Risk-based Approach to Audit Trails
PLUS! CHOOSE BETWEEN THREE INTERACTIVE WORKSHOPS
- Develop, Implement and Maintain a Risk-Based CSV Program
- Streamline CSV Processes through a Paperless Validation Strategy
- Prepare and Write Auditor, Inspector and Tester- Friendly Test Scripts