Featuring
> Ann Gulau – Manager II, Operational Quality, Pharma Solutions, IFF
> Jennifer Putnam – Analytical R&D Senior Supervisor, Perrigo
> Priscilla Zawislak - Global Regulatory Affairs Advocacy Manager, IFF
Description
The presentation will focus on:
> Fundamental principles for managing changes related to excipient manufacturing and supply
> The role of risk assessment in evaluating change
> Excipient manufacturer (maker) best practices and case studies for evaluating changes for level of significance
> Finished drug manufacturer (user) best practices and case studies for managing significant changes
Learning/Awareness Objectives
Attendees will be able to:
> Apply the principles outlined in the IPEC Significant Change Guide for Pharmaceutical Excipients
> Understand why evaluation and notification of significant change is important
> Identify the difference between a significant and non-significant change
> Implement best practices for notification of significant changes
Who should attend?
> Excipient manufacturers, users, distributors
> Regulatory affairs
> Compendial affairs
> Quality affairs
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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.