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
Topic: A Risk-based Approach to AIQ and Method Validation – The Future in Validation for Personalized Medicine
Date and Time: 5th June 2024 @ 10:30 – 12:00 EST
Speakers:
🎤 Rob Eleuterio: Senior Manager – Validation, Compliance Group
Topic: The Fundamentals of Data Integrity (DI) in the Lab – How to Modernize your DI Practice
Date and Time: 6th June 2024 @ 8:50 – 10:20 EST
Speakers:
🎤 Rick Dursch: Director of Data Integrity and Software Validation, Compliance