KENX 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

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

Date & Time: June 4th 2024 - June 6th 2024
Location: 2001 Market Street Philadelphia, PA, United States