CMC Development Strategies to Prevent Rework and Delays

Inefficiencies and errors in Chemistry, Manufacturing and Controls (CMC) development are a leading cause of regulatory delays, cost overruns and compromised product quality. As regulatory expectations evolve and product pipelines become more complex, life sciences organizations face growing pressure to modernize legacy CMC practices and mitigate risks early in development. This webinar will examine strategies and digital advancements that can minimize errors, streamline processes and ultimately optimize CMC development.

The featured speakers will start by outlining the fundamental ideas that underpin successful CMC procedures. From there, they will examine common challenges that often disrupt success, which may include inconsistent risk management activities, fragmented data sources, version control challenges and gaps in cross-functional collaboration. These pain points often lead to inefficiencies, increased costs and delayed regulatory submissions.

The webinar will also explore how risk-based decision-making, structured data management and enhanced knowledge exchange can help businesses better manage complexity and promote continuous improvement. By contrasting traditional techniques with more contemporary, integrated methods, the session will highlight ways to reduce variability and strengthen a culture of informed decision-making. Real-world case studies will demonstrate how various companies have transitioned from disconnected tools to fully integrated digital platforms.

Whether at the beginning of the CMC journey or seeking to refine existing practices, this session will provide practical guidance on how to proactively reduce errors, strengthen collaboration across teams and build a resilient foundation for long-term success in CMC development.

Register for this webinar to learn how to reduce delays and improve efficiency in CMC development.

Speaker

Margarida Ventura, Senior Consultant, ValGenesis

Margarida Ventura is a Senior Consultant in Quality Risk Management (QRM) at ValGenesis with over five years of experience in the pharmaceutical and biopharmaceutical sectors. She has led QRM implementations across the US, Brazil and Europe, helping clients improve efficiency and meet regulatory standards. In addition to her consulting work, Margarida supports the development of ValGenesis iCMC. Her expertise in QRM and digital solutions drives continuous improvements to the platform, enabling clients to manage risk and compliance effectively.

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