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STABILITY TESTING & PROGRAM MANAGEMENT

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June 22, 2020 - June 24, 2020

San Diego, United States

Stability Testing & Program Management Excellence

 

Stability testing is critical to the efficacy of drug substances. ICH, FDA and WHO stability guidance’s have been around for quite some time and are strictly enforced, however, industry still has challenges to overcome and seeks more direction. The time has never been more critical to evaluate your program and ensure your organization has an advanced, compliant processes that exceed the expectations of regulators.  KENX is pleased to announce that our comprehensive Stability Testing & Program Management is headed to San Diego to showcase programs and procedures that excel and avoid regulatory action.

 

Stability Leaders Showcase Best-In-Class Programs

 

  • Develop and Validate Stability-Indicating Analytical Methods
  • Learn How to Perform Risk-Based Stability Testing
  • Build and Manage a Stability Program from the Ground Up
  • Establish Change Control Procedures for Stability Programs
  • OOS/OOT – Learn How to Handle Testing Variation
  • eStability – Automate Drug Stability Reporting Validation Procedures
  • Use Container Closer System Integrity Testing as a Stability Protocol
  • Apply Bracketing and Matrixing Designs for Testing
  • Evaluate overall Photosensitivity through Forced Degradation Testing Studies
  • Discover the Most Effective Approach for Evaluating Stability Data
  • Stability Data Integrity – Implement a Governance Program
  • Manage Storage Conditions in Zones III and IV
  • Predict Shelf Life through Accelerated Testing
  • FDA Inspections – Prepare for an FDA Audit
  • Case Study – Implement a Stability Program for Medical Device Manufacturing

 

Personnel in the Following Environments Should Attend:

  • Development and Manufacturing – (Bio)pharmaceutical, API and Medical Device
  • QA/QC
  • Stability Laboratories
  • Raw Materials
  • Laboratory Management
  • Regulatory Affairs
  • Formulation

This event is also appropriate to business development and sales managers that offer innovative solutions for QC testing laboratories, data collection, and statistics.

 

For an additional $995, you can earn 1.5 graduate credit hours towards Temple’s RAQA Graduate Program! For more information on the Temple Track for Lab University, email info@kenx.org, or call 856-281-7134.

 

CLICK HERE FOR A SNEAK PEEK AT THE AGENDA

Agenda

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Faculty

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Sponsors


  • Since 1949, Ellab is a leading manufacturer of a full line of wireless, real-time data loggers and wired thermocouple validation systems with temperature, humidity, pressure, vacuum, conductivity and CO2 sensor options. Additionally, Ellab offers temperature standards, calibration dry blocks and liquid baths, custom fittings, accessories, and thermocouples. We also offer on-site qualification, validation and calibration services for thermal validation processes ranging from -196°C to 400°C. Typical environments often include -80°C freezers, incubators, stability chambers, autoclaves, and ovens.
    Website: https://www.ellab.com/

Partners

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Venue

Details

Start:
June 22, 2020
End:
June 24, 2020
Event Category:
Website:
https://www.kenx.org/events/lab-data-integrity-2019/

Venue

San Diego, CA
San Diego, CA 92109 United States + Google Map

Pricing & Registration

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