TechTalk: When the process shifts: Tracing CMC evidence from investigation to decision
Friday, November 13 at 16:30 GMT | 17:30 CET | 11:30 EST | 08:30 PST
When a process begins to behave differently, CMC teams need to understand why. They need to investigate potential causes, determine which parameters may be affecting product quality, generate evidence to reach a decision, and retain the scientific rationale behind what happens next.
Join Marc Smith, Value Stream Director at IDBS to see how IDBS Polar supports this workflow in practice. Starting with multi-batch process data, the demonstration will follow an observed shift in a critical quality attribute through investigation and risk assessment, into a small-scale design of experiments (DoE) study to understand the parameters influencing process performance.
The resulting evidence remains connected to the evolving process definition as operating ranges and parameter classifications are reviewed, necessary process updates are made and their impact is confirmed.
By connecting investigation, experimental evidence and decisions, CMC teams can preserve how and why the process evolved, keeping that knowledge available for future use across process development, technology transfer and regulatory filings, while creating a stronger foundation for emerging applications such as AI.
Certificate of attendance
If you attend the live TechTalk, you will automatically receive a certificate of attendance, including a learning outcomes summary, for continuing education purposes. If you view the on-demand TechTalk, you can request a certificate of attendance by emailing editor@selectscience.net.
TechTalk details
- Cost: Free to attend
- Location: Online
- Duration: 20 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?
A senior CMC audience e.g. VP CMC, Director of CMC, Head of CMC, VP Process Development, Senior Director Process Dev/CMC, and CMC program directors.
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IDBS Polar
IDBSIDBS Polar is a next-generation enterprise lab informatics platform that unifies ELN, LIMS, and LES capabilities into a single powerful data management system, purpose-built for both GxP-regulated and non-regulated laboratory environments.
What will this webinar cover?
- How multi-batch process data can reveal and support investigation of shifts in process performance
- How risk assessment and DoE can help determine which parameters may influence product quality
- How experimental evidence can inform operating ranges, parameter classifications, and the evolving process definition
- How connecting evidence, decisions, and scientific rationale preserves CMC knowledge for reuse across development, technology transfer, regulatory filings, and future applications