Key revised IPEC Guides: What you need to know!

Friday, November 4, 2022 - 9:00am

The recently re-issued IPEC Certificate of Analysis Guide for Pharmaceutical Excipients.  The primary goal of the guide is meant to provide best practices for the preparation and appropriate use of a Certificate of Analysis (COA) for pharmaceutical excipients.  

The webinar will also review the recently re-issued IPEC Stability Guide for Pharmaceutical Excipients.  The primary goal of the Stability Guide is to offer best practice and guidance in the establishment of an excipient stability program andis intended to provide excipient manufacturers with strategies for assessment of overall stability. It also provides  an approach for a manufacturer to establish a stability study program which may be used to support regulatory filings, aid in maintaining the quality of the excipient, and define  substantiate recommended storage conditions and shelf-life claims (e.g., re-evaluation date, expiration date, and use-by by date).  

Learning/Awareness Objectives
> Overview of both the IPEC Certificate of Analysis Guide for Pharmaceutical Excipients and the IPEC Stability Guide for Pharmaceutical Excipients, including recent major changes
> Understanding of best practices for COA
> Understanding of excipient stability, the stability program for excipient and differences between excipient and API stability
> Define COA roles and responsibilities for the excipient manufacturer and distributor
> Clarification of key points and terminology for both guides (e.g., retest date, identification testing, compendial compliance)

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

Note:

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
E-mail: ipecamer@ipecamericas.org

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.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3449 or email ipecamer@ipecamericas.org