Revised IPEC Significant Change Guide

Thursday, March 23, 2023 - 9:00am

Ann Gulau – Manager II, Operational Quality, Pharma Solutions, IFF
Jennifer Putnam - AR&D Senior Supervisor, Perrigo

The presenters provided an overview of  the recently re-issued IPEC Significant Change Guide for Pharmaceutical Excipients.  The primary goal of the guide is to establish a uniform approach to evaluate the significance of changes involving the manufacture and distribution of excipients.  The guide was originally published in 2000, followed by revisions in 2005, 2009 and 2014.  

The 2023 revision better aligns with general IPEC guideline policies and formatting with limited changes to content

This webinar focusedf primarily on the differences between the 2014 guide and 2023 guide.  The webinar is not intended to provide comprehensive training on the content of the guide.

Learning/Awareness Objectives
Learning objectives for this webinar include:
> Brief background and history of the IPEC Significant Change Guide for Pharmaceutical Excipients
> Overview of best practices
> Review of recent high-level changes

Who should attend?
Personnel from excipient manufacturer, user and distributor regulatory, quality, R&D, formulation, purchasing, manufacturing and supply chain areas would benefit from attending this 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