Three Events | One Location | Endless Learning

Laboratory University: Mastering Analytical Methods, Stability Testing, and QC Excellence brings together three in-depth events in one location, offering attendees a robust agenda packed with multiple sub-tracks that cover the latest regulations, industry trends, and core areas of interest in laboratory operations. Customize your learning experience by selecting from over 50 knowledge exchange tutorials, each led by industry experts and designed to help you stay at the forefront of laboratory management, quality control, and regulatory compliance.

Why Attend Laboratory University?
This unique event is designed for laboratory professionals looking to enhance their expertise across a range of specialized areas. With sessions covering analytical procedures, stability testing, lab management, and quality control, Laboratory University offers everything you need to ensure your lab operates at the highest standards of efficiency and compliance.

Key Topics Covered:

Analytical Development

• Advanced Analytical Techniques and Automation
• Analytical Method Validation Lifecycle: Emphasis on robustness, risk management, and continuous improvement
• Artificial Intelligence/Machine Learning: Applications in method optimization and data analysis
• Challenges of ICH Q14 Method Development: Quality by Design, Established Conditions
• Pharmaceutical Impurities: Advanced profiling and regulatory-driven analysis

Stability Testing

• ICH Q12 Implementation: Streamlined post-approval changes for stability protocols
• Nitrosamine Risk Assessment: Stability-focused impurity monitoring
• Long-term Stability Predictions: Using predictive models with real-time data
• Accelerated Stability Programs: Balancing speed with accuracy for early-phase development
• Stability Program for Biologics: Trials and Tribulations

Laboratory Management

• Digital Transformation: Adoption of LIMS (Laboratory Information Management Systems) and automation
• Data Integrity: Ensuring compliance in managing lab-generated data
• Resource Optimization: Balancing capacity and personnel for peak efficiency
• Risk-based Auditing: Focusing audits on critical lab activities and high-risk areas

Good Manufacturing Practices

• Global Harmonization: Aligning GMP requirements across jurisdictions
• Annex 1 Updates: Implementation of sterile manufacturing revisions
• Supply Chain Integrity: Mitigating risks in raw material sourcing and traceability
• Continuous Process Verification: Real-time quality monitoring
• Training and Competency: Enhancing GMP culture among staff

Quality Systems

• Quality Risk Management (QRM): Enhanced use of risk-based approaches in decision-making
• Digital Quality Systems: Transitioning to e-QMS for automation and efficiency
• Post-Approval Change Management: Streamlining global regulatory submissions
• Data Integrity Assurance: Strengthening controls for electronic systems compliance
• CAPA Effectiveness: Improving corrective and preventive action follow-through

Method Validation

• Lifecycle Approach: Implementing ICH Q14 and Q2(R2) guidelines for continuous validation
• Platform Methods: Validation for multiple products with minimal customization
• Robustness Testing: Incorporating DoE (Design of Experiments) for stronger validations
• Method Transfer Challenges: Overcoming variability in global sites
• Validation for Novel Therapies: Addressing specific needs for cell/gene therapy methods

Analytical Investigations

• Root Cause Analysis (RCA): Expanding the use of advanced tools like Ishikawa and 5-Whys
• Proactive Deviation Trending: Identifying patterns before they escalate into issues
• Human Error Reduction: Enhancing training and process simplification to minimize mistakes
• Real-Time Investigations: Faster response with digital tools and AI
• Cross-Functional Collaboration: Involving diverse teams to improve investigation quality

Laboratory Inspections

• Remote and Hybrid Audits: Adapting to evolving inspection formats post-pandemic
• Focus on Data Integrity: Scrutiny of electronic records and audit trails
• Supply Chain Oversight: Inspectors targeting outsourced activities and suppliers
• Inspection Readiness Programs: Simulations and pre-audit gap assessments
• Global Regulatory Trends: Preparing for regional-specific inspection focus areas

Key Highlights:

• In-Depth Training Sessions: Access targeted training that covers everything from analytical validation to quality control best practices.
• Expert Panels & Case Studies: Hear from laboratory management experts as they address today’s biggest challenges, discuss recent success stories, and share actionable insights.
• Networking & Collaboration: Connect with professionals, vendors, and industry thought leaders for valuable networking and collaboration opportunities.
• Hands-On Workshops: Engage in interactive workshops where you can practice real-world solutions and troubleshoot specific lab challenges.

Who Should Attend?
Laboratory University is ideal for laboratory managers, quality control professionals, and anyone looking to stay current with regulatory requirements and industry best practices. Whether you’re new to lab management or an experienced professional, this event offers the knowledge, skills, and resources needed to advance your lab’s operations.

Don’t Miss Out!
Join us at Laboratory University to gain the insights, tools, and connections needed to elevate your lab’s performance and ensure compliance. With over 50 tutorials, hands-on workshops, and expert-led panels, this event is your complete resource for laboratory excellence.

Register today and secure your place at the premier laboratory event!