Laboratory University

LABORATORY UNIVERSITY

Laboratory University contains 3 amazing events at one location! Each event contains a packed agenda with multiple sub-tracks of current regulations, industry trends and key areas of interest. Create your own event by choosing from over 50 knowledge exchanges tutorials, including:

Analytical Procedures & Methods Validation

• Documentation and Revalidation Strategies after Method Changes
• USP General Chapter <1220> Overview and Implementation Roadmap
• Assay Transfer, Qualification, Validation – Are We Living in a ‘Land of Confusion'?
• Analytical Method Development Using QbD
• Validation of the Stability-Indicating Profile of a Biological Product
• Monitoring Organic Impurities: The Dynamic Impact of USP General Chapters <476>, <477>, and <1086>
• Equipment considerations when executing Analytical Method Transfer

Stability Testing & Program Management

• Key Learning to Set Up Stability Studies at CROs
• Mapping Stability Functions – Your Program in the Big Picture
• Revision of ICH Q1 (R2) Requirements - The Future of Stability Studies
• Compendial Resources to Support Modern Technologies, Including Physical Stability and Continuous Manufacturing
• Stability of Combination Products - How to Utilize Worst Case to Bracketing & Matrixing Study Designs
• Designing Phase-Appropriate Stability Program
• Developing Structured Process to Evaluate Data

Lab Management and QC Excellence

• FDA’s New Update of OOS Guidance (05/2022) - What It Means for You
• Reducing and Handling Out of Specification (OOS) / Out of Trend (OOT) Test Results
• Identify Root Cause and Implement Corrective Action
• Effective Laboratory Workflows to Improve Efficiency and Productivity
• How to Graph and Analyze Data for Decision Making
• Set and Evaluate the Performance of Specifications

Personnel in the Following Environments Should Attend:

Validation

QA/QC

Scientist

Chemist

Laboratory Management

Regulatory Affairs

Data Integrity

This event is also appropriate to business development and sales managers that offer innovative solutions for QC laboratory management, validation departments, data collection and statistics.

Host or Publisher Knowledge Exchange Network