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Best Practices for Communicating Nitrosamine Strategies Between Makers and Users

Description



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/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

Contributors

  • Elizabeth Tocce

    Associate Scientist, Application Development & Innovation, IFF

    Elizabeth is an associate scientist for IFF Pharma Solutions (previously DuPont Pharma Solutions) and is an active member of the IPEC-Americas Nitrosamine Cross Functional Team and Quality-by-Design Committee. Elizabeth Tocce joined the IFF Pharma Solutions team in 2018 as a Pharma Application Development Scientist. In this role, she provides technical support to pharmaceutical customers and project leadership on growth and innovation projects using IFF’s pharmaceutical excipients. Prior to her role with IFF, Elizabeth was a research and development scientist for The Dow Chemical Company’s Pharma & Food Solutions excipient business where she led R&D projects in areas of specialty oral solid dosages and quality improvement. Elizabeth received her PhD in Chemical and Biological Engineering from the University of Wisconsin – Madison in 2011 and a bachelor’s degree in Chemical Engineering from Purdue University in 2005.

  • Ron Kelly

    Sr. Principal Scientist, Attribute Sciences, Amgen

    Ron C. Kelly is a Sr. Principal Scientist at Amgen, Inc. He received his PharmD degree from Xavier University of Louisiana and Ph.D. from The University of Michigan, Ann Arbor in Pharmaceutical Sciences. Prior to joining Amgen, Ron was a Research Investigator at SSCI, Inc. where his responsibilities included crystal form screening and characterization, small scale crystallization development, and stabilization of amorphous systems. Ron joined Amgen’s Pharmaceutical Research & Development (PR&D) – Preformulation organization in 2006 where his responsibilities included molecule assessments, preclinical formulation development, and identifying crystal forms for clinical development. In his current role, Ron is a member of the Materials Science group within Attribute Sciences where he provides leadership for technical raw material initiatives including support for the expansion into the China market and readiness for addressing global raw material trends impactful to Amgen including nitrosamines. Ron is an active member with IPEC-Americas, serves on the IPEC-Americas Executive Committee, and leads the IPEC-Americas Nitrosamine Cross Functional Team.

  • Jennifer Nette

    Senior Manager, Analytical R&D- New Product Development, Raw Materials Characterization, Perrigo

    Degree: BS Biology, Western Michigan University

    Jennifer has 27+ years in the pharmaceutical industry applying analytical risk-based Quality by Design principles to new product development, especially as it relates to raw materials. She currently leads teams at Perrigo responsible for raw material characterization, establishing specifications, developing and validating test methods, performing technical transfer, and authoring various regulatory documents (includes FDA-related ANDA or NDA Common Technical Document analytical sections). In addition to her formal responsibilities, she and her analytical R&D team are often sought out at Perrigo for their problem solving & root cause analysis skills to help teams develop and implement applicable CAPAs and since 2019, Jennifer continues to significantly contribute to Perrigo’s n-nitrosamines team.

August 31, 2021
Tue 11:00 AM EDT

Duration 2H 0M

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