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Digital CMC: The Key To Realising Pharma 4.0 Training Course

Whether you’re looking to optimise existing processes or lay groundwork for a digital transformation, the course will teach the tools to leverage Digital CMC as a cornerstone of Pharma 4.0 success.

7 April 2025
+ 7 July 2025, 1 December 2025 »

from £649

Need help?  Enrol/reserve

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CMC processes often become bottlenecks, impeding progress due to their reliance on manual workflows, siloed data, and outdated systems.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 pharma and biotech companies that have successfully implemented Digital CMC solutions, demonstrating their impact on product lifecycle management and regulatory compliance.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

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 ideal for personnel in these departments:

  • MS&T
  • Process development
  • Technical operations
  • CMC
  • R&D
  • Quality assurance
  • Manufacturing
  • Supply chain
  • Business IT professionals (R&D IT and manufacturing IT etc.)

More broadly, any professionals working in a digital capacity within any of the aforementioned domains within a pharmaceutical/biotechnology organisation. This course is suitable for all levels (scientists, managers, and senior leadership).

Enrol/reserve

This course will cover:

Industry forces pressuring pharmaceutical and biotech companies to increase operational efficiency

  • An industry failing to commercialize its exquisite scientific breakthroughs
  • Companies facing elongated development timelines & rising development costs
  • Companies facing increased competition across all therapeutic modalities
  • Traditional data management practices unable to handle the exponential growth of
    data

Recognising the CMC bottleneck

  • Diagnosing the cause of the bottleneck: unstructured & siloed CMC information
  • Why unstructured & siloed CMC information is a burden for the whole organisation
  • Why today’s technology stack falls short when it comes to resolving this

Digital CMC represents a novel solution

  • The need to structure and centralise CMC information
  • How to build a CMC source of truth using a 3-step framework
  • Proposing a grand vision for CMC to alleviate the bottleneck

Leveraging digital CMC to drive operational & regulatory efficiencies

  • Building a digital bridge between development & manufacturing; accelerating
    technology transfers
  • Connecting technical requirements (product/process) to business requirements
    (demand/supply planning)
  • Accelerating business process execution across the entirety of technical operations
  • Enhancing data integrity by building traceability between information sets irrespective of their origin (internal/external) or location (document/digital system)
  • Enabling organisations to develop & demonstrate enhanced product & process
    understanding

Demonstrating digital CMC via cloud-based software platform

  • Deep dive: digital product definition
  • Deep dive: digital process definition
  • Deep dive: digital control strategy
  • Deep dive: digital technology transfer
  • Deep dive: automating development reports, visualisations and regulatory filings

Real world use cases of digital CMC

  • Case study: top 10 pharmaceutical company
  • Case study: top 10 pharmaceutical company
  • Case study: top 25 pharmaceutical company
  • Case study: top 25 pharmaceutical company
  • CasesStudy: top 50 pharmaceutical company

Enrol/reserve

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. 

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

7 April 2025

Live online

09:00-16:00 UK (London) (UTC+01)
10:00-17:00 Paris (UTC+02)
04:00-11:00 New York (UTC-04)
Course code 15544

  • GBP 649 749
  • EUR 909 1,049
  • USD 1,043 1,199

Until 03 Mar

View basket 

 
Not ready to book yet?

for 7 days, no obligation

7 July 2025

Live online

09:00-16:00 UK (London) (UTC+01)
10:00-17:00 Paris (UTC+02)
04:00-11:00 New York (UTC-04)
Course code 15545

  • GBP 649 749
  • EUR 909 1,049
  • USD 1,043 1,199

Until 02 Jun

View basket 

 
Not ready to book yet?

for 7 days, no obligation

1 December 2025

Live online

09:00-16:00 UK (London) (UTC+00)
10:00-17:00 Paris (UTC+01)
04:00-11:00 New York (UTC-05)
Course code 15546

  • GBP 649 749
  • EUR 909 1,049
  • USD 1,043 1,199

Until 27 Oct

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Run Digital CMC: The Key To Realising Pharma 4.0 Live online for your team

1 day

Typical duration

Pricing from:

  • GBP 500
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy