This webinar is intended to provide attendees with an understanding of the fundamental sources and types of components that might be present in an excipient. It will also offer best practices for characterizing an excipient composition profile and discuss potential analytical variabilities and limitations.
In addition, presenters will suggest best practices for excipient manufacturers to communicate composition information with users and regulators while avoiding potential pitfalls.
Learning/Awareness Objectives
Attendees will be able to:
> Define fundamental excipient components.
> Understand potential implications from stability and safety information.
> Responsibilities for excipient manufacturer and excipient user when exchanging composition information.
> Identify potential pitfalls to avoid.
> Establish best practices for communicating excipient composition information.
Who should attend?
> Excipient manufacturers, users, distributors
> Regulatory affairs
> Compendial affairs
> Quality affairs
> Regulators
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Note: Did you know this webinar may count toward continuing education credits? Check with your credentialing organization to confirm. A certificate of participation will be available for download upon completion of the webinar.