US Laws, Regulations and Industry Best Practices for Excipients

Wednesday, October 20, 2021 - 9:00am
Thursday, November 4, 2021 - 9:00am

This webinar was intended to provide a road map for how the regulatory process in the US works relative to the use of excipients and will focus on requirements for: 

1. Excipient manufacturers/suppliers
2. Drug manufacturer/excipient users
3. US FDA drug application reviewers

Learning/Awareness Objectives

1. Understanding of responsible regulatory agencies and standards for excipients
2. Excipient information necessary for supporting drug applications
3. Requirements and resources needed for filing and maintain a US Type IV DMF
4. Regulatory considerations for Atypical Actives, colorants/flavors and biological adjuvants.
5. Evolution from bundling review, to registration to joint review of excipients used in drug
6. Emerging hot topics and challenges impacting excipients

Who should attend?

> Excipient manufacturers, users, distributors 
> Regulatory affairs
> Compendial affairs
> Quality affairs

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