Computer Software Assurance & Systems Validation

Implement Programs that are Compliant, Smart and Progress with Today’s Evolving Technology

April 7, 2021

10:00 AM – 5:00 PM EST 

This fall, FDA plans to release a draft guidance on Computer Software Assurance! Are you prepared? To this day, Computer Systems Validation, Software Assurance and Data Integrity challenges remain high in our rapidly changing, highly regulated environment. In fact, FDA and other agencies continue to find serious findings. KENX is proud to present this virtual training that help you master the innovative processes, techniques and compliance trends to make an immediate impact in your organization.

Top Reasons to Attend

• Understand FDA’s Computer Software Assurance (CSA) Guidance
• Align CSA with Current Regulations and GAMP®
• Modernize Testing in Preparation for CSA – Software Quality Assurance 101
• Learn the Steps to Transform Your Computer Systems Validation (CSV) Program to CSA
• Apply CSA to Data Integrity
• Develop Critical Thinking and Risk-Based Approach to CSV
• Part 11 Regulatory Requirement Assessment – Security, Audit Trail and E-signature
• Develop a Strategy for Periodic Review and Revalidation – Continuous Monitoring
• Ensure Change Management Reviews are Practical and Achievable
• Conduct a Part 11 Gap Analysis – Create a Checklist
• Validate Manufacturing Automation Systems
• Qualify Network, Cloud, and IT Infrastructures
• Learn a Practical Approach to Spreadsheet Validation
• Conduct a GAP Assessment of Your Program – Inspection Readiness

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, data collection and statistics.