Stability Testing & Program Management Excellence

Stability testing is critical to the efficacy of medical products. ICH, FDA and WHO stability guidance’s have been around for quite some time and are rigorously 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 advanced, compliant processes that exceed the expectations of regulators.

Stability Leaders Discuss the Critical Elements of a Successful Program

KENX-PSDG Stability Track Topics

  • Stability Stakeholders
  • Inventory Systems
  • Monitoring Systems
  • Vaccines/Biologics/Gene Therapies Stability
  • Stability Budgeting
  • Stability Data Integrity
  • Photostability
  • Extractables & Leachables
  • Innovative Labeling
  • Stability Protocols
  • Top 10 Stability 483s
  • Stability Training
  • Reference Standards Stability
  • Stability Windows
  • Shipping Studies
  • Stability Automation
  • Equivalence Studies
  • Devices/Combination Products
  • Clinical Supplies Stability
  • Stability Review Boards
  • Validating & Operating Stability Chambers
  • Stability Statistics & Reports
  • Laboratory Information Management Systems
  • Best Practices in using Contract Stability Organizations
  • International Stability Regulations
  • Sample Handling

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.

Pricing & Registration

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.