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Home
Upcoming Trainings
Conferences
Webinars
Focus Areas
AI
CSV/CSA
Device
GMP
Laboratory
Sterility
Validation
Content Format
Conference Recordings
Webinar Recordings
Market Insight
Bonus Material and Resources
Membership Plan
Sign-in
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Conference Sessions Recordings
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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
CSV UNIVERSITY - 2025
CSA Implementation – Industry Case Study That Inspires Success
Risk-Based Validation Strategies for Software Upgrades
Governing AI Data: Real vs. Synthetic Integrity Challenges
Guardrails: The AI Revolution and the Human in the Loop
Webinar Recordings
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White Paper: Modernizing Validation and Engineering in Life Sciences
Validation & Engineering Convergence: How Digital, Cloud, and AI Are Reshaping Processes
AI in GxP: What's Next for 2026?
Validation Documentation: Common Pitfalls, Best Practices, and the Role of AI
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
Market Insight
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Industry Insight: Top 10 Validation Challenges Life Sciences Teams Are Solving in 2026
Industry Insight: Top 10 Engineering Challenges & How Pharma Leaders Are Solving Them in 2026
Article: Digitize Your Audit Trail Reviews for Faster Compliance Decisions
White Paper: Managing Nitrosamine Risks Across the Product Lifecycle
White Paper: 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
Article: Breaking Down Risk for Medical Device Hazard Analyses
Article: Improving Risk-Based Decision Making Effectiveness: Insights From Other Industries
Article: Fit for Intended Purpose- Key Concept in USP General Chapters and ICH Guides
Article: Implementing ICH Q12 to Enhance the Stability Program
Article: 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
Bonus Material and Resources
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Industry Guidance: Computer Software Assurance for Production and Quality Management System Software
Industry Guidance: EJSP: Artificial intelligence-driven pharmaceutical industry (2024)
Industry Guidance: Regulatory Focus: Bach Uniformity and Drug Product Integrity
Industry Guidance: ICH: Stability Testing of Drug Substances and Drug Products Q1 (2024)
Industry Guidance: EudraLex Volume 4: Good Manufacturing Practice Guidelines: Chapter 4, Annex 11 and New Annex 22 (2024)
Industry Guidance: FDA: 21 CFR Part 4 (July 2024)
Industry Guidance: FDA: Q2(R2) Validation of Analytical Procedures (March 2024)
Industry Guidance: FDA: Guidance AI Enabled Device Software Functions (January 2025)
Industry Guidance: FDA: Control of Nitrosamine Impurities in Human Drugs (September 2024)
Industry Guidance: FDA: Outsourcing Facility Inspection Guide
Industry Guidance: FDA: FY2024 Report on the State of Pharmaceutical Quality (2024)
Recent Webinar Recording
Validation & Engineering Convergence: How Digital, Cloud, and AI Are Reshaping Processes
Webinar Validation & Engineering Convergence: How Digital, Cloud, and AI Are
Recent Items
Industry Insight: Top 10 Validation Challenges Life Sciences Teams Are Solving in 2026
Industry Insight: Top 10 Engineering Challenges & How Pharma Leaders Are Solving Them in 2026
Upcoming Conferences
Pharmaceutical Engineering Summit
Validation University
Harness the Power of AI in GxP
Laboratory University
GxP Supply Chain Summit
Upcoming Webinars
Method Validation & Stability Testing Modernization: What Labs Need to Update
