Using AI in CMC: Opportunities, Challenges and Solutions

Using AI in CMC: Opportunities, Challenges and Solutions
The CMC SPIN Steering Group is pleased to present this technical webinar, which explores the opportunities for utilizing AI in the Quality and Manufacturing space, along with the challenges to and how to address them to meet regulatory guidelines.




 

  
Date: 31/07/2025
Time: 12:00 - 13:00 BST/13:00 - 14:00 CEST
         

Suitable for

TOPRA Members and TOPRA Special Interest Groups (SPINs) interested in Regulatory Quality/Chemistry Manufacturing and Controls (CMC), artificial intelligence (AI) and Machine Learning and those who are interested in opportunities in, concerns about, and solutions to using AI in CMC optimisation.

Benefits for participants

       •   Stay updated: Learn about the evolution, uptake, and concerns about AI technologies transforming CMC.
       •   Practical strategies: Gain actionable implementation insights to successfully integrate AI into operations.
       •   Expert guidance: Benefit from specialised knowledge on AI governance, compliance considerations, and best
           practices.

Description

The webinar will consist of two 15-minute presentations by industry leaders with regulatory and consultancy backgrounds, followed by a Q&A session - please feel free to send questions/requests for topics to discuss when you register.

Topics to be covered in the webinar, using case studies and personal experiences
Embrace AI as a Partner

Peer-reviewed studies by Harvard/MIT business schools and BCG confirmed that AI-assisted consultants outperformed their non-AI-powered colleagues. They were faster, more creative and analytical. The key? Collaboration, not competition.

Benefits of using AI in the CMC space

       •   Revolutionising product release: by developing an AI tool to assist the QP.
       •   Cutting deviations by 60%: AI can pinpoint problem clusters to prevent deviations happening.
       •   SOP simplification at scale: Over one hundred SOPs simplified and redesigned in just 5 hours. SOP
            noncompliance – dramatically reduced.
       •   Rapid validation protocols and reports – completed in minutes.
       •   Helping solve complex problems like media fill failures.
       •   Optimised training programmes: AI enhanced education improved workplace behaviours and Quality 
           Culture.
       •   Accelerate change control: AI prioritised and assessed change requests in minutes.
 
Thriving in an AI-Driven World

       •    AI enabled or extinct: The future belongs to companies (and people) who integrate AI. Those that don’t will
              struggle.
       •    AI is not infallible: AI doesn’t ‘know’ anything, including right from wrong.  It’s a prediction machine. It can
             fabricate (‘hallucinate’). Human oversight is VITAL.
       •    AI as a co-intelligence: It’s a tool to be used and must never become the ‘Master Craftsman’.
       •    Master prompting: Great outputs require great inputs (questions/prompts).
       •    Build AI literacy: Empower your workforce to understand AI, reducing fear and resistance. You must win
             hearts and minds first.
       •    AI in every meeting: It's great at brainstorming and creative problem solving BUT you MUST direct it, don’t 
            defer to it.
       •    Simplify first: AI alone will have little impact unless systems are simplified, and hierarchies/bureaucracies
            (and other historical artifacts) removed. 
       •    Establish guardrails and controls: Especially in GMP settings so that AI serves, not hurts, the patient. AI must
            remain a tool, directed and controlled by humans.
       •    Develop and retain expertise: AI elevates the importance of experts who validate and guide its outputs.  You
             must upskill your entire workforce.
 
Speakers



Mark Birse, Vice President - Strategic Compliance Consulting at Parexel
   
Mark Birse has over 30 years’ experience of influencing within the pharmaceutical, biotechnology, medical device and life sciences sector, with a proven track record of challenging norms, developing innovative solutions to issues, and enhancing regulatory compliance. A passion for delivering regulation in a risk proportionate way and establishing pragmatic, forward-thinking approaches to regulatory oversight; specifically, development of interventional educational approaches to enhance compliance. 

Former Head of the UK Medicines & Healthcare Products Regulatory Agency (MHRA) Inspectorate with recognised national and international influence through being a member of the PIC/S Executive Bureau and engagement in global-level conferences and inter-agency meetings.
 



Martin Lush, Independent Consultant and Educator

Martin is an Executive Leader in Biotech Operations & QP, a GxP AI Adoption Readiness/Implementation Specialist, AI Governance & Ethics Board Member, Educator in AI literacy (basic - advanced), and Expert auditor in AI applications & SaaS. He has 40 years’ leadership experience in pharmaceutical and health care (vaccines, biologics, injectables) from the shop floor to C Suite. Previously Vice President of Global Services at NSF International, he has held senior leadership positions in global consulting/training, manufacturing, operations, supply chain, and QA (regulatory compliance). Martin has set up an AI in Pharma LinkedIn discussion group and posts regularly about how AI learnings from general use apply to the pharma CMC space – the lists above are adapted from one of his posts.

Pricing

TOPRA Members: Free
Non-members: £45
When
31/07/2025 12:00 - 13:00
Where
ONLINE
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