COMPUTER SYSTEMS VALIDATION & SOFTWARE ASSURANCE UNIVERSITY

December 6th – 8th

With FDA’s heightened focus on Software Assurance and Data Integrity – Computer Systems Validation has taken on a new movement initiated by regulatory authorities. In fact, FDA has taken the lead with a proposed guidance on Computer Software Assurance and is asking firms to rethink their approach. With that said, the challenges remain high in our rapidly changing environment. In fact, inspectors continue to find serious findings such as – interrupted, missing, deleted and lost data; inadequate records for risk analysis; failure to exercise appropriate controls; failure to validate computer software; failure to establish validation procedures; manipulation and deletion of audit trails; and many more. The time has never been more critical to evaluate and ensure your organization has top-notch compliant procedures.

Choose from Over 40+ Tutorials Addressing Today’s Top Challenges

COMPUTER SYSTEMS VALIDATION AND SOFTWARE ASSURANCE

• Critical Thinking and the CSA Movement – Rethink Your Approach to Traditional CSV
• Sustain and Build a Quality Culture in Today’s Realities
• Learn Machine Learning and AI Validation Strategies
• Modernize Risk Management in Software Testing
• Implement Risk Management in Cloud-based Platforms
• Design and Qualify Spreadsheets for Use in cGXP Environments
• Modernize the Periodic Review Process
• Enable Continuous Delivery of Software and Regulated Environments
• Validation Community of Practice – Effective Collaboration Across CSV Teams
• Managing Global Infrastructures and Data Centers
• Implement Effective System Configuration and Change Management Processes
• Validate Mobile Applications
• Create and Use a Checklist for Conducting a GAMP®5 Assessment

DON’T MISS THIS CRITICAL UPDATE

Stay Up To Speed with FDA’s Computer Software Assurance Initiative:

PLUS! A SPECIAL FOCUS ON

DATA INTEGRITY GOVERNANCE AND INSPECTION READINESS

• The Interrelationship Between Data Integrity and CSA
• Build and Manage a Data Integrity Program
• Construct of a Program from the Ground Up
• Auditing Data Flows for Integrity and Compliance
• Implement an Effective Audit Trail Review Process
• Corrective Action in Data Integrity Lapses – Develop a Roadmap
• Implement a CAPA Process – What to Do When Things Go Wrong

Personnel in the Following Environments Should Attend:

• Validation
• Quality Assurance
• Engineering
• IT
• Data Integrity
• Quality Control
• Manufacturing Management
• Laboratory Management
• Regulatory Affairs

This event is also appropriate to business development and sales managers that offer innovative solutions for quality departments, validation departments, paperless validation platforms, and validation consultant services.