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CMC processes often become bottlenecks, impeding progress due to their reliance on manual workflows, siloed data, and outdated systems.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 exciting lunchtime session 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
CPD Hours: 1
Speakers
Lewis Shipp
Lewis Shipp is a published pharmaceutical scientist and a recognised expert in drug development & manufacturing across a range of therapeutic modalities. Lewis currently works at the intersection of science & technology as a Digital CMC Specialist at QbDVision, helping organisations both large & small leverage digital technology to accelerate the delivery of therapies to patients. Additionally, Lewis has contributed to ISPE's Pharma 4.0 Special Interest Group & BioPhorum's Technology Strategy Forum as an SME in the application of digital technology to solve business process challenges within the pharmaceutical industry. Lewis has also given several presentations at internationally recognised conferences on varying topics pertaining to digitally-enabled drug development and manufacturing.
