Laboratory University

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 Procedures & Methods Validation

• Documentation and Revalidation: Strategies to adapt post-method changes effectively.
• USP General Chapter <1220>: An overview and implementation roadmap for critical standards.
• Assay Transfer and Validation: Navigating challenges in transfer, qualification, and validation.
• Method Development Using QbD: Insights into Quality by Design (QbD) for analytical methods.
• Biological Product Stability: Approaches to validate stability-indicating profiles.
• Organic Impurity Monitoring: Impact of USP General Chapters <476>, <477>, and <1086>.

Stability Testing & Program Management

• Stability Studies at CROs: Key takeaways for setting up studies with contract research organizations.
• ICH Q1 (R2) Revision: Insights into the evolving future of stability study requirements.
• Compendial Resources: Tools to support modern technologies, including physical stability.
• Combination Product Stability: Effective bracketing and matrixing study designs.
• Phase-Appropriate Programs: Designing stability programs for different development phases.

Lab Management and QC Excellence

• FDA’s Updated OOS Guidance: Understanding the latest Out of Specification (OOS) guidance from May 2022.
• OOS and OOT Handling: Reducing, identifying root causes, and implementing corrective actions.
• Effective Laboratory Workflows: Strategies to improve lab efficiency and productivity.
• Data Analysis for Decision Making: Techniques to graph, analyze, and use data in decision-making.
• Performance Specifications: Setting and evaluating performance metrics for laboratory success.

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!

Host or Publisher Knowledge Exchange Network