The Webinar will address the following:
What content is expected in filings to demonstrate Elemental Impurity compliance for drug products? What type of information might be expected from suppliers? What is industry hearing from FDA after review of the filing information that has been submitted? The answers to these questions and more – along with a clarification of ICH Q3D requirements in light of recent FDA feedback from these reviews will be provided.
After the webinar, participants will:
• Understand ICH Q3D requirements for suppliers and drug product manufacturers.
• Gain a perspective on how FDA is responding to information submitted.
• Learn about IPEC-Americas efforts to engage FDA to address misunderstandings related to implementation of Elemental Impurity reporting.
Who should attend?
• Excipient manufacturers, users, distributors
• Regulatory affairs
• Compendial affairs
• Quality affairs
LEARN MORE – REGISTER: https://ipecamericas.org/excipient-learning-lab/webinars/elemental-impurities-filing-experiences-what-industry-hearing-fda