About the Webinar
Are you a drug sponsor or manufacturer responsible for overseeing or implementing post-approval changes in small molecule products? In today’s evolving regulatory environment, timely and compliant execution of these changes is crucial for maintaining product integrity and avoiding costly delays. Whether you're navigating updates in formulation, manufacturing processes, or packaging, understanding how to properly characterize and file these changes with the FDA is essential to avoid delays, non-compliance, or product shortages.
Through a combination of real-world case studies and expert insights, we will walk you through the steps required to assess proposed post-approval changes, streamline internal processes, and submit changes effectively to regulatory authorities with confidence. You'll gain valuable knowledge on how to handle urgent modifications while ensuring your regulatory filings are accurate, compliant, and timely.
What You Will Learn
- Key considerations for characterizing and assessing post-approval changes in small molecule products.
- Best practices for preparing and submitting accurate and timely changes to the FDA.
- Insights from case studies on how to implement urgent changes while maintaining compliance.
Who Should Attend?
This webinar is ideal for:
- Managers and leaders of people who are dealing with changes to their products (planned or unplanned)
- Technical professionals working in operations, research and development, regulatory affairs, and quality assurance
Unable to join? Register and you will receive the recording after the live session.
