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Stability Testing & Program Management Excellence

: 22 Jun 2020 - 24 Jun 2020

: San Diego, United States

Sector: Pharmaceutical

Type: Conference, Meeting, Training


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.

 

  • 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
Venue

San Diego
United States


Organizer

KENX Knowledge Exchange Network
Phone: 858 649 3251
Email: info@kenx.org
Visit: https://www.kenx.org/


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