VENUE

Hotel To Be Announced | Philadelphia, PA











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

  • Critical aspects of ICH Q14 and how to develop an implementation plan
  • Using Statistical Methods to Meet ICH Q14 Requirements
  • Analytical Method Bridging and Equivalence Testing
  • Setting acceptance criteria for validation
  • Develop a trending program to monitor organic impurities
  • Validation and transfer of Analytical Methods for Biologics
  • Analytical Instrument Qualification to Support Method Lifecycle
  • Method validations by product Lifecycle Stage – from Phase 1 to Commercial
  • Analytical Method Lifecycle – monitor method performance

Stability Testing & Program Management

  • Challenges of Using Predictive Stability Concept – Case Studies
  • Stability Beyond ICH:  In-Use and Excursion studies
  • Develop, Implement and Maintain a Risk-Based Stability Program
  • Different Approaches to Addressing Cumulative Stability Requirements
  • Effectively Apply Q1E Guidance to Evaluation of Stability Data
  • Developing Change Control Strategies for Stability Program Post-Approval Changes
  • Develop an Effective Protocol for Conducting Transportation Studies
  • Stability Reports:  What to do and how to explain your Stability Data effectively
  • Challenges with Vaccine Stability Program – Case Studies
  • Prepare the Stability Area for Regulatory Inspection
  • Understand Statistical Modelling and Evaluation of Stability Data
  • Stability Chambers Selection, Validation, and Calibration

Lab Management and QC Excellence

  • Identifying Error By Conducting an Effective Laboratory Investigation
  • Using Data Analytics to Effectively Manage the Laboratory
  • Effectively Handle Stability Deviations and Investigations
  • QC Lab Data Integrity Programs – Development, Implementation and Maintenance
  • Preparation for Laboratory Inspections (data integrity, LIMS, documentation)
  • Data Integrity Compliance – Create Your Custom QC Lab Audit Checklist
  • Use of an integrated Electronic Lab for Maintaining Data Integrity
  • Manage Data Integrity Inspections and Respond to Findings
  • Conducting a Mock Audit – How to Prepare and Handle FDA Inspections

For An Additional $995, You Can Earn 1.5 Graduate Credit Hours Towards Temple’s RAQA Graduate Program! For More Information, Email INFO@KENX.ORG, Call 856-281-7134 or Register Above.

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.