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    An Oxford Roundtable

    Quality under scrutiny

     

    As AI reshapes quality management and regulatory expectations continue to evolve, quality leaders face growing pressure to build inspection-ready quality systems.

     

     

    Hosted by:

    Scilife + RiverArk
    An Oxford Roundtable | Scilife + RiverArk

    About the event

    Join RiverArk and Scilife in Oxford for an afternoon of expert talks, peer discussion, and practical insights from former MHRA inspectors on managing quality, risk, and compliance in the age of AI.

    Date

    9 September 2026

    Location

    St Anne's College, Oxford

    Room

    Seminar Room 8, cabaret style

    What we'll cover

    • AI governance frameworks and practical controls for regulated quality systems.
    • Inspection readiness and evolving regulatory expectations from former MHRA inspectors.
    • Building quality into products and processes through Quality by Design.
    • Continuous quality governance with real-time visibility into quality performance.
    • Applying Computer Software Assurance (CSA) to modern digital validation.
    • Vendor oversight and supplier risk management in an AI-enabled world.

    Agenda

    Guest arrival and registration
    1:30 PM – 2:00 PM 
    Welcome
    2:00 PM – 2:10 PM 

    Opening remarks from Scilife and RiverArk

    1st Talk - Panel Discussion: Inspection Readiness- what does it mean in the real world? What QA and senior Ops teams should know
    2:15 PM – 3:15 PM 

    Hear from former MHRA inspectors on today's regulatory expectations and how to keep your QMS inspection-ready.

    Refreshment break
    3:30 PM
    2nd Talk -  AI Governance: Frameworks and controls
    for adopting AI responsibly within a regulated quality system
    3:45 PM – 4:15 PM 

    Explore practical frameworks and controls for adopting AI responsibly within regulated quality systems.

    3rd Talk - Continuous Quality Governance: Moving
    from periodic reviews to real-time oversight of quality performance
    4:15 PM – 5:00 PM 

    Discover how continuous oversight and real-time visibility can strengthen quality performance.

    4th Talk - Expert Roundtable: Vendor Oversight in the World of AI. Managing supplier and vendor risk as AI
    tools enter the supply chain
    5:00 PM – 6:00 PM  

    Discuss practical approaches to managing supplier and vendor risk as AI becomes part of the quality ecosystem.

    Networking Reception, drinks and canapés
    6:00 PM – 7:00 PM 

    Continue the conversation over drinks and canapés with speakers and industry peers.


    Speakers

    Our speaker lineup is currently being finalized. Confirmed speakers include:

     

    Sarah

    Sarah Hitching

    Sarah Hitching is a highly experienced TMFs expert who set up Hedian Records Management (Hedian) in 2018.

    Hedian provides TMF services and contract staff to the pharmaceutical and medical devices industry, specialising in TMF Quality Control (QC) and TMF Inspection Readiness for pharmaceutical companies with little or no TMF experience.

    Sarah has worked in a GCP environment for more than 30 years as a CRA, Project Manager/ Director then specialising in TMFs from 2005. Sarah is a member of CDISC and the Health Sciences Records and Archives Association (HSRAA), recently contributing to the CDISC TMF Risk Initiative, working on the White Paper and the Training subgroup, sitting on the CDISC Conference Agenda team where she was recently elected to serve on the European teams.

    Chris-

    Christopher Hayden,
    Head of Industry and Partner Relations, Scilife

    Mandy-

    Mandy Webb,
    Associate Director Clinical Quality Assurance, Jazz Pharmaceuticals


    Mandy Webb is a distinguished senior leader in Clinical Quality Assurance, bringing over 30 years of specialized experience in the pharmaceutical industry, including a decade of impactful leadership at Jazz Pharmaceuticals. With a core focus on Good Clinical Practice (GCP) compliance, Mandy has successfully overseen quality for global clinical trials from concept to completion.

    Mandy’s expertise lies in GCP auditing, inspection preparation and management, and quality oversight, where she champions a proactive, pragmatic approach cantered on risk-based and fit-for-purpose quality management. Mandy is committed to driving operational excellence, mitigating compliance risks, and protecting patient safety and data integrity, paving the way for life-changing therapies to reach the market efficiently and safely.

    Jennifer martin

    Jennifer Martin,
    Principal Former-MHRA, GCP Consultant, Kingfisher Quality Consulting Ltd.

    Jenny Martin is a pharmaceutical quality and GxP compliance expert with over 30 years’ experience across industry and regulation. A former MHRA GCP Lead Senior Inspector and Operations Manager, she has contributed to major UK and EU GCP guidance and worked with global regulators including the EMA and FDA. Jennifer advises organisations on pragmatic, risk-based approaches to inspection readiness, regulatory intelligence, quality impact assessment and continuous improvement.

    Milind Nadgouda,
    RiverArk

    David Caine,
    Director of Quality, InovX Pharma

    Additional speakers to be announced:

    Former MHRA inspectors

    RiverArk auditors and quality experts