Submission readiness is built, not reconstructed: Connecting CMC knowledge for Module 3
Monday, November 2 at 14:00 GMT | 15:00 CET | 10:00 EST | 07:00 PST
Why do chemistry, manufacturing, and controls (CMC) and regulatory teams still spend significant time searching for evidence, validating historical decisions and reconstructing the scientific rationale behind established processes?
The challenge is rarely a complete absence of data. More often, the connections between product requirements, experiments, risk assessments, process parameters, and the decisions they support have weakened as information moves through development, scale-up and technology transfer. By the time Module 3 is being prepared, teams may be able to find the final value without being able to easily recover why it was selected or how it was justified.
This webinar will explore how CMC organizations can make submission readiness an outcome of the development process. Bringing together industry perspectives and practical experience, it will examine the information that needs to remain connected, where knowledge is most at risk across the lifecycle, and the steps organizations can take to make CMC evidence easier to reuse, interpret and defend.
Certificate of attendance
If you attend the live webinar, you will automatically receive a certificate of attendance, including a learning outcomes summary, for continuing education purposes.
If you view the on-demand webinar, you can request a certificate of attendance by emailing editor@selectscience.net.
Webinar details
Cost: Free to attend
Location: Online
Duration: 60 minutes
Registration is required to secure your place. If you register but can’t attend live, you will receive a link to the on‑demand recording once it becomes available.
Speakers
Who should attend?
- VP CMC
- Director of CMC
- Head of CMC
- VP Process Development
- Senior Director Process Dev/CMC
- CMC program directors
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What will this webinar cover?
- How knowledge and traceability gaps created during development, scale-up and technology transfer can affect Module 3 preparation.
- Which connections between product requirements, scientific evidence, process parameters and decision rationale are essential to submission readiness.
- How more connected CMC data and knowledge strategies can support an evidence-based, defensible regulatory narrative.
Links
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