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

Learning Objectives

Learning/Awareness Objectives
Attendees will be 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

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