Thursday, March 23, 2023 - 9:00am to 10:30 am EDT
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 focused 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.