Conference day one


Registration and refreshments


Speed networking

Marie-Laure Bas

Lean Six Sigma: The ins and outs

•    Lean Six Sigma : what’s that?
•    How is it related to MES?
•    How can it help us?
Mr Martin Fusek

The MES Core Approach Boon and Bane – A Site Point of View

•    Introduction of the Sandoz MES Core approach
•    Example of onsite implementation
•    Evaluation of the pros and cons of an MES core approach from a site point of view

Automation and Continuous Manufacture

Automation and continuous manufacture

How to provide a cost effective support model for complex multi-site and legacy MES environments

•    Based on our customer experience we discuss - What is the industry need?
•    An overview of the specific challenges in supporting disparate MES technologies
•    Going above and beyond normal IT support
•    Best practice support frameworks
•    Practical application based on real-life example
•    Critical success factors in creating and delivering support
Automation and continuous manufacture

A Fearless Approach to Continuous Manufacturing

•    Challenges implementing CM require deep process understanding at unit op level
•    Material tracking/data alignment/segregation strategy – all have to mesh
•    PAT data can be leveraged for IPC & RTRT strategies
•    Full support of internal stakeholders is critical

Morning refreshments

Automation and continuous manufacture

Small, Agile Factories: How to deliver Intelligent Intensified Processes, with the Agility Required for Pharmaceutical Manufacture

•    Smart Modular Building Block Library for Pharma
•    Rapid Integration in to new facility concepts
•    Intensified processing challenges and how to overcome them
Claudia Facchi

MES/EBRS maintenance: Back office experience


Roundtable session

Smart manufacturing
  • Discuss how MES provides the fundamentals of smart manufacturing
  • Review the technologies to ease smart manufacturing
    • IoT
    • The Cloud
    • Analytics
    • Mobile devices
  • ROI of creating a connected system – lessons learnt
    Oleg Savin, MES expert, Sibur

  • Latest developments and future trends in serialisation and Track and Trace
  • Roadmap to serialisation – explore proven methods to implementing your strategy
  • Data management – what is the best way to centrally manage serial numbers?
Automation hosted by Schneider Electric
  • Discuss operational platforms of the future
  • Risk based approaches to choosing and implementing your automation platform
  • Explore flexible, validated and ready to use architectures
  • Automation
  • Serialisation
  • Smart manufacturing
  • 12:55


    QbD/PAT Developing a New Paradigm

    QbD/PAT developing a new paradigm

    PAT tools for automation of batch and continuous biotech processes

    •    PAT in Biotech
    •    PAT Setup for Process Development
    •    Applying PAT for CPPs and CQAs in a Continuous Downstream Process
    QbD/PAT developing a new paradigm

    Smart MES solution as a tool for PAT continuous improvement in process industry

    •    Objectives and positioning of Smart MES as a PAT tool in Continuous Improvement Cycle  
    •    Interrelationships and dependencies between shop floor and business KPIs in Smart MES  
    •    Digitized dynamic model of manufacture process 
    •    Architectural approaches or solutions for Smart MES 
    •    Criteria and sources of efficiency of Smart MES
    QbD/PAT developing a new paradigm

    Practical experience with QbD and PAT for Freeze & Spray Drying Processes

    •    Sources of variability in freeze & spray drying Processes
    •    Applying QbD in freeze & spray drying process optimization
    •    PAT for freeze & spray drying processes

    Sponsor Speaking Slot Available

    Do you offer QbD/PAT solutiosn for Pharma?
    If so, we'd like to hear from you. 
    Contact Edmond Rama on +44 (0) 207 092 1052 or email:


    Afternoon refreshments

    Dr Lisbeth Gdalia

    Quality control road map

    •    QC vision and objectives
    •    QC roadmap supported by
    o    LIMS
    o    Laboratory execution system
    o    Electronic note book
    •    Integration with Learning management system
    •    Key success factors
    Panel discussion

    Panel discussion: Structured risk-based approaches to process development

    •    Using risk analysis to improve efficiency
    •    How to maintain a well performing and compliant process using quality risk management 
    •    Using risk for continuous improvement of manufacturing processes
    •    Case study examples on speaker’s experiences

    Evening drinks reception

    last published: 18/Nov/16 12:15 GMT