Validation University

Welcome to Validation University, the premier event for QA, Validation, Engineering, IT, and RA professionals working in the pharmaceutical, biopharmaceutical, and medical device industries. This comprehensive program is designed to equip you with the latest tools, techniques, and insights to navigate today’s regulatory landscape and enhance your validation processes. With a focus on cutting-edge technologies, emerging trends, and practical applications, Validation University is your gateway to achieving compliance and operational excellence.

Highlighted Sessions

Explore a diverse range of sessions designed to deepen your expertise and provide actionable insights across key validation areas.

• Modernizing Process Validation: Strategies for Stage 1-3 Compliance and Efficiency
• CSV 4.0: Validating AI, SaaS, and Cloud-Based Systems
• Continuous Validation: Staying Compliant in Rapidly Evolving Environments
• Next-Gen Cleaning Validation: Integrating Risk-Based Approaches and Visual Inspection
• Risk-Based Approach to Computer Systems Validation: Simplifying Compliance
• Ensuring Compliance: Utility Qualification for Water, HVAC, and Compressed Air Systems
• Advanced Statistical Approaches: Process Capability, Sampling Plans, and Control Limits
• Facility Qualification: Ensuring Regulatory Compliance Through Effective Design and Execution
• Quality Risk Management (QRM): Integrating ICH Q9 into Validation Processes
• Automated Validation Systems: Reducing Human Error and Increasing Efficiency

 

Industry & Emerging Trends

Stay ahead of the curve with sessions that delve into the most transformative trends shaping the industry today:

• Adopting Industry/Pharma 4.0: Integrating AI and Machine Learning into Validation (Panel)
• Digital Validation Tools: Harnessing Data Analytics and Predictive Modeling for the Future (Panel)
• Driving Collaboration: Standardization and Best Practices Through Information Sharing
• Computer Software Assurance (CSA): Shifting from Compliance to Critical Thinking
• Validation in Continuous Manufacturing: Ensuring Compliance in Real-Time Processes
• Lean Validation: Driving Efficiency and Reducing Costs in Complex Projects
• Data Integrity Beyond ALCOA: Addressing Current Challenges in Digital Validation
• Validation Master Plans: Blueprinting Success for Compliance and Efficiency
• Single-Use Systems in Validation: Balancing Flexibility and Compliance
• Audit Trails: Ensuring Data Integrity in a Digital Era

PLUS: So Much More!

Take advantage of exclusive opportunities to connect with industry experts, participate in engaging roundtable discussions, and learn the latest insights in validation practices. The program is packed with expert-led sessions, interactive panels, and unique networking opportunities tailored to meet the needs of today’s validation professional.