Membership Product Catalog

Validation University 2025

• What is QRM Based Qualification
• Continuous Monitoring in Utility Systems Ensuring Validation Integrity
• Successfully Implementing CSA Company Wide Across Multiple Regulations

Laboratory University 2025

• New USP General Chapter on Biologics Stability: Advancing Standards for Quality and Shelf-Life Assessment
• Critical Aspects of Stability in Pharmaceutical Products – From Performance and Expiry to Lifecycle Management and Product Investigations
• Beyond ICH Q1A(R2)-The Stability Lifecycle

CSV UNIVERSITY - EUROPE 2025

• Regulatory perspectives navigation AI compliance challenges in GxP environments
• Risked Based Impact Assesments Scripted vs Unscripted Testing for Criticality

HARNESS THE POWER OF AI IN GXP - USA 2025

• AI without DI
• Regulatory perspectives navigation AI compliance challenges in GxP environments

STERILITY ASSURANCE 2025

• Strategies to Reduce Data Integrity Issues in Environmental Monitoring
• Cleaning Validation Lifecycle: From Development and Acceptance Limits to Continuous Verification
• Mastering Media Fills: Designing, Executing and Interpreting Aseptic Process Simulations

MEDTECH VALIDATION 2025

• Change Control for Computerized Systems and Software Upgrades
• Integrating Cybersecurity into Risk Management: Threat Modeling and Pen Testing in Action
• Strengthen Postmarket Surveillance with Actionable Tools
• Leverage CSA: Use Cases on Risk-Based Software Validation

GMP UNIVERSITY 2025

• Digital Transformation in GMP Labs: Managing Risk, Efficiency, and Inspection Readiness
• Surviving a Data Integrity Audit: Red Flags, Best Practices, and Lessons Learned
• Modernizing GMP Quality Systems: From Risk to Remediation in an Evolving FDA Landscape

• Getting Started with AI in GxP — Real World Use Cases in Life Sciences
• Webcast: AI & Data Integrity: Navigating Compliance in the Digital Age
• Webcast: AI for Process Optimization: How to Improve Manufacturing Efficiency
• Webcast: Establishing the Right Data Building Blocks for a Successful AI Program
• Webcast: Outsourcing Pharmaceutical Manufacturing - New Regulatory Guidance and Use of Contract Facilities 
• Webcast: AI in MedTech - Automation, Optimization, and Compliance
• Webcast: Microbial Contamination: Common Pitfalls and How to avoid them
• WEBCAST: Audit-Ready at All Times: Streamlining GxP Computerized Systems Compliance and Inspection Preparedness
• Webcast Series: Strengthening Laboratory Data Integrity: Regulatory Frameworks for Control and Security
• AI in GxP: Opportunities, Challenges and Industry Guidance
• Modernize Risk Assessments by Using Critical Thinking

• Managing Nitrosamine Risks Across the Product Lifecycle
• FD&C Red No. 3: The FDA Ban, the Delaney Clause, and the Fallout for Pharma and Food
• White Paper: Data Pedigree – Getting to Know Your Data
• White Paper: Digital and AI-Enabled GMP Systems: Enhancing Compliance, Data Integrity, and Operational Efficiency
• White Paper: Evolving from ALCOA+ to DYNAMIC+: A Modern Framework for Data Integrity
• Breaking Down Risk for Medical Device Hazard Analyses
• Improving Risk-Based Decision Making Effectiveness: Insights From Other Industries
• Fit for Intended Purpose- Key Concept in USP General Chapters and ICH Guides
• Implementing ICH Q12 to Enhance the Stability Program
• Use Statistical Thinking and Methods to Make Better Decisions - Dr. Ron Snee
• White Paper: Human Contamination and Controlled Access in Clean Room Environments – Compliance with Annex 1, Paragraph 7.2