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Implement an Effective, Compliant Program that Ensures Efficacy, Safety and Product Survival

December 4-6, 2017
  • Philadelphia, PA

As the regulatory landscape shifts and drug approval processes continue to become more complex, now more than ever it is critical for life sciences companies to ensure sound stability testing standards to assess drug safety and efficacy. From reviewing core FDA and ICH guidance to breaking down the latest regulatory policies, including a brand new updated WHO draft guidance for API and finished drug stability testing, IVT’s annual Stability Testing is the flagship event for stability professionals to convene in order to develop and hone your organization’s stability testing procedures.

Whether you are new to stability testing or a veteran stabilitarian, this event provides the ideal platform for scientists, chemists, quality control, laboratory and stability professionals to gain insight on the latest updates and challenges including off-label storage, change management, lean stability processes, comparability studies, risk analysis, stability chamber excursions, forced degradation and much more!

NEW THIS YEAR!

BYOC — Bring Your Own Challenge Workshop

Practical Applications for Critical Method Validation Procedures

Lina Patel, PhD
Director, Quality Operations Bio-Analytical Laboratory
Merck Manufacturing Division

Office Hours!

Gain insights on your individual laboratory and method validation challenges by meeting one-on-one with Lab Week speaking faculty.

Engage in 16 Interactive Courses and
Critical Discussions, Including:

  • Risky Business — Exploring the Importance of Applying Risk Assessment to Stability Functions
  • Investigate OOT and OOS in Stability Studies Conducting Excipient Compatibility Studies (ECS)
  • Special Applications of Accelerated Stability Modeling for Drug Products Excursions, In-Use Applications and Table Dissolution
  • Stability Not Covered by ICH
  • Regulatory Snapshot — Update on Guidances in Analytical Methods, Stability Testing and Lifecycle Laboratory Management
  • Mitigating Data Integrity Risk in Analytical Methods and Stability Testing
  • Lifecycle Management in the Laboratory
  • How to Handle Stability Chamber Excursions

Download the Lab Week Preview

Previous Attendee Acclaim:

This conference provided with excellent direction and advice that I can use and apply within my own organization.

QC Supervisor, Edgewell Personal Care

Great networking opportunity. Great information.
I learned many new things that I had not even considered
as part of my stability program.

Senior Research Associate, Alkermex

IVT consistently assembles the best Subject Matter Experts to address the latest challenges in the stability arena.

Principal Scientist, Genentech