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 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.