Speakers for this Event: Wei Pan, Ph.D. RAC, Senior Manager, Catalent Pharma Solutions Kathy Waddle, Director, Stability QC Biology, Catalent Pharma Solutions

Sponsored by:

Stability studies are a critical part of the drug development process and are essential for drug product marketing approval.

Stability studies are conducted at all phases of the drug development cycle for different purposes with the ultimate goal of having a stable product on the market.  During development, stability studies are conducted to support the formulation development and safety and efficacy claims of investigational new drugs.  At registration, they are conducted to ascertain the quality and shelf-life of the drug product in their intended packaging configuration.  After approval, the stability studies are conducted to ensure the quality of production and to support site or other changes to the product.

• This webinar will address the principles and practices of stability studies in the drug development process.
• It will discuss the framework of the FDA cGMP guidelines as expressed in 21CFR 211 which will help pharmaceutical analysts to understand the process.
• It will also provide a comprehensive review of the ICH and WHO stability guidelines and discuss the strategy used in stability protocols design to support global registration. 

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