Excipient Stability – Use of expiration/retest dates and accelerated aging

Wednesday, September 29, 2021 - 10:00am

Excipient stability regulations are different than that of drug product and API, but have similar expectations.  While many excipient products are stable and may not require extensive testing to assure stability, the stability of excipients is an important factor contributing to the overall quality of the drug product.  This webinar has been designed provide an overview for why excipient stability data is needed and discuss when special stability studies/data may be necessary and/or desired.

Learning/Awareness Objectives

Attendees will be provided with an understanding for:
> why excipient stability data is necessary
> what stability testing should include
> definition for common stability terms
> overview of IPEC Excipient Stability Program Guide (2010)
> overview of IPEC position paper on excipient stability
> current thoughts on climate zone stability studies, expanding retest intervals and temperature cycling/shipping studies

Who should attend?
> Excipient manufacturers, users, distributors
> Regulatory affairs
> Compendial affairs
> Quality affairs

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