Be In the Know With Pharma 4.0: Digital CMC

Part of Lunch & Learn: Be In the Know With Pharma 4.0 series:

Course overview

The pharmaceutical and biotech industries are under increasing pressure to enhance operational efficiency, meet evolving regulatory requirements, and accelerate time-to-market while maintaining product quality. These demands, coupled with the complexities of global supply chains and the need for seamless collaboration across diverse teams, highlight the critical role of Chemistry, Manufacturing, and Controls (CMC) in ensuring success. However, traditional CMC processes often become bottlenecks, impeding progress due to their reliance on manual workflows, siloed data, and outdated systems.

Digital CMC offers a transformative solution, leveraging digital tools, data analytics, and integrated platforms to reimagine CMC processes. This course introduces participants to the concept of Digital CMC within the broader context of Pharma 4.0, a vision for the future of pharmaceutical development and manufacturing that emphasises agility, automation, and data-driven decision-making.

Through this interactive session, participants will explore the industry forces driving the shift toward digital transformation, understand the specific challenges Digital CMC addresses, and learn about its operational and regulatory advantages. The course will also provide actionable insights through case studies from global pharmaceutical and biotech companies that have successfully implemented Digital CMC solutions, demonstrating their impact on product lifecycle management and regulatory compliance. Whether you’re looking to optimise your existing processes or lay the groundwork for a comprehensive digital transformation, this course will equip you with the knowledge and tools to leverage Digital CMC as a cornerstone of Pharma 4.0 success.

Key topics covered in this course include:

• What is Pharma 4.0?
• What is Digital CMC?
• What is the relationship between Pharma 4.0 & Digital CMC?
• Recognising the CMC bottleneck
• The need to structure and centralize CMC information
• How to build a CMC source of truth using a 3-step framework
• Leveraging Digital CMC to drive operational and regulatory efficiencies
  Real world use cases Of Digital CMC

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

By the end of this course, participants will be able to:

• Identify the key challenges driving the need for pharmaceutical and biotechnology organisations to increase their operational efficiency
• Understand the role of Digital CMC in addressing traditional bottlenecks in pharmaceutical development and manufacturing
• Assess the operational and regulatory benefits of adopting Digital CMC practices
• Analyse case studies showcasing the successful implementation of Digital CMC in leading pharmaceutical and biotech organisations
• Develop a roadmap for integrating Digital CMC into their own organisational workflows to enhance efficiency and regulatory compliance

Who should attend?

This course is suitable for all levels (scientists, managers, and senior leadership), but ideal for professionals in:

• MS&T
• Process development
• Technical operations
• CMC
• R&D
• Quality assurance
• Manufacturing
• Supply Ccain professionals.
• Business IT professionals (R&D IT and manufacturing IT for example)
• Professionals working in a digital capacity within any of the aforementioned domains within a pharmaceutical/biotechnology organisation. 

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