Best Practices for Communicating Nitrosamine Strategies Between Makers and Users

Tuesday, August 31, 2021 - 11:00am

Nitrosamines and related compounds continue to be a hot topic among regulatory agencies globally.  

Regulators are asking drug product manufacturers to identify products at risk of N-nitrosamine formation or contamination, which could impact the pharmaceutical industry supply chain.  

This webinar provided an update on regulatory expectations for assessing, testing and reporting of nitrosamines and/or their potential formation in drug products.  In addition, the webinar included best practice strategies and examples for ongoing communication between excipient suppliers and users.

Learning Objectives

Learning/Awareness Objectives
Attendees were provided with:
> Background and overview of regulatory expectations relative to excipients, including a review of regulatory changes in the past 12 months
    – Need for drug product manufacturers to complete testing for nitrosamines in their drug products based on risk assessment outcomes  
> Discussion of additional support that may be requested from excipient suppliers, based on confirmatory test results
    – Potential supplier response to user needs (based on IP, capabilities, competitive intelligence, etc.)
> Options for excipient users to use information obtained from their excipient supplier in the identification of products at risk of N-nitrosamine formation or contamination 
    – Tips for effective communications between excipient suppliers and users 
    – Feedback from users on what has worked well vs what has been a challenge
> Proposed best practices and strategies for ongoing communication between excipient suppliers and users
    – information required for new excipients
    – information needed when current excipient information changes 
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