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IMPLEMENTING A RISK-BASED APPROACH TO STABILITY FROM DEVELOPMENT THROUGH COMMERCIALIZATION

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Stability testing is an activity which is crucial in supporting both the development and the commercialization of pharmaceutical products. Depending on phase, there are different study objectives as well as stability study requirements which need to be addressed. Product development is accelerating, the pharmaceutical industry is becoming more global, and many companies are being asked to do more with fewer resources. Introducing a risk-based approach to the design and execution of product stability studies has become key, and understanding the risks and rewards of such designs is crucial.

 

By participating in this presentation, you will learn:

  • What the minimum requirements are for each type of study?
  • What region-specific requirements need to be considered?
  • How can Quality Risk Management be used for stability studies?
  • What are some examples of acceptable risk-based approaches to stability?
  • How can stability data be used as leverage to satisfy multiple requirements?

 

The Webinar will focus on understanding how Risk Management can be built into stability programs and the best practices for each phase. Specifically, we will review:

  • ICH Q9 Quality Risk Management
  • Stability requirements in global markets
  • How stability studies can be designed to support multiple objectives
  • Examples of risk-based stability study designs
  • Current industry trends for the acceptance of risk-risked based stability studies

 

Speakers

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