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Developing and Selecting Methods for Evaluating Product Characteristics

Wednesday, May 10, 2017 at 11:30AM - 2:30PM

Online Event

  • May 2017

    10 Wed

    11:30AM

  • May 2017

    10 Wed

    2:30PM

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Developing and Selecting Methods for Evaluating Product Characteristics

Wednesday, May 10, 2017 at 11:30AM - 2:30PM

Fremont, CA

No tickets available

Description
The goal of this presentation is to provide information on what is expected for stability studies at different program stages. This will include discussions of what items are required vs. nice to have at each stage, as well as discussing how best to develop and select methods for use in evaluating product characteristics during real time and accelerated storage.

Objectives Of The Presentation
  • Developing phase appropriate methods
  • Applying forced degradation to confirm stability indicating nature of methods
  • Fit for use and assay qualification studies - when are they necessary and how is the data applied?
  • Stability study design and execution
  • When/how should extended characterization methods be applied to stability studies?
  • Evaluation of stability data
Why Should you Attend
  • To gain a better understanding of assay development practices, especially as they relate to stability studies
  • To understand agency expectations for stability programs at different clinical stages
Areas Covered
  • Assay development
    • General principles
    • Forced degradation studies
  • Assay qualification study design and execution
    • What is a complete study?
    • What are the GMP requirements?
  • Stability study design and execution
    • What timepoints and which assays at each timepoint
    • Implementation of extended characterization methods into stability studies
    • Evaluation of stability data
Who will Benefit
  • Stability program leads
  • Analytical development scientists
  • Regulatory / CMC leads
  • Quality control managers
  • Stability coordinators
  • Laboratory directors
  • Stability department personnel
  • R&D laboratory personnel
  • R&D laboratory supervisors and management
  • QC laboratory personnel and management
  • Protein formulation group personnel and management
  • Regulatory affairs personnel & Regulatory affairs management.


For Registration

http://onlinecompliancepanel.com/webinar/GLP-GMP-STABILITY-STUDIES-505403/MARCH-2017-ES-EZEVENT


Note: Use Promo code PTY2D and get 10% off on registration (Valid till MARCH 31st 2017)

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