Skip to main content

Recording: Expectations for Developing and Sharing Excipient Composition Information

Tuesday, October 10, 2023 - 10:00am to 12:00pm EST

> David Schoneker – Chair of IPEC-Americas QbD/Composition Committee; IPEC-Americas Executive Committee Emeritus Member; Owner of Black Diamond Regulatory Consulting, LLC
> Paul Smutz–Global Compliance Manager, Henkel Corporation
> Elizabeth Febbo – Global Laboratory and Project Manager, Henkel Corporation
> Joe Zeleznik – Technical Director, North America at IMCD

This webinar provides attendees with an understanding of the fundamental sources and types of components that might be present in an excipient. It also offer best practices for characterizing an excipient composition profile and discusses potential analytical variability and limitations.

In addition, presenters 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.
> Identify responsibilities for excipient manufacturer and excipient users when exchanging composition information.
> Discuss 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

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.