Managing Excipient Significant Change: Best Practices

Wednesday, November 8, 2023 - 10:00am

> 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

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

Save When You Bring Your Team
Register your staff using the same email domain to take advantage of our "Buy 4 get 1 Free" offer. Contact us for more information.

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.

Cancellation Policy


Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street N
Arlington, VA 22201
Suite 500

Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you registered and are unable to attend the webinar, a recording of the webinar will be provided.

No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Please contact IPEC-Americas Training Coordinator
571-814-3449 or email