CSV & Software Assurance University is industry’s largest and most comprehensive program focused on CSV that attracts 200 – 300 participants from the life science industry working in engineering, validation, quality, software development, IT, and regulatory compliance. The multi-track conference offers 40+ tutorials exchanging best practices and sharing challenges including digitization, technology advances, Data Integrity, critical thinking, risk analysis, evolving and traditional CSV trends and dives into emerging challenges such as superintelligence governance, AI/ML, ChatGPT and more. This year, we expect a large turnout because of a myriad of regulatory guidance and trends in AI/ML, CSA, Annex 11 and more. This must attend event includes:
Create Your Own Experience by Choosing from Over 40+ Tutorials, Including:
FDA and Industry Panel Discussions
• Stay Up to Speed with the Evolving Regulatory Landscape for AI, ML and Superintelligence Technology
• The Impact of CSA on Part 11, GAMP® 5, Risk Analysis, Critical Thinking and Test Scripts
Use Cases in Emerging Technology and Top Compliance Trends
• CSA Transition Success
• Artificial Intelligence / Machine Learning Qualification
• Super Intelligence Usage and Governance
• Cloud Platform Qualification
• Data Integrity Maturity Model Implementation
• Risk Analysis and Critical Thinking
Technology Advancement Impact on Traditional CSV Practice
• Spreadsheet Qualification
• Unscripted vs. Scripted Testing
• Risk-based Impact Assessments
• Decommissioning of Systems
• Change Control and Configuration Management
• Program and Process Innovation
• SOPs, Checklists, and Master plans
• Cybersecurity Modernization
PLUS! Attend an Inclusive Digitalization Validation Demo Workshop
• Save Time and Money, Ensure Compliance, Minimize Error/Risk, and Increase ROI
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.
Speakers:
🎤 Khaled Moussally: EVP Quality – Clients & Regulatory Relations, Compliance Group Inc.
🎤 David Deluca: Director, Engineering & Validation, Compliance Group Inc.
🎤 Jason Spiegler: SVP – Strategy Sales & Marketing, Compliance Group Inc
🎤 Jonathan Meuzelaar: Director, Quality Systems, Compliance Group Inc
🎤 Francisco Vicenty: Case for Quality Program Manager, U.S. FDA
🎤 Daniel Walter: Policy Analyst at FDA