Day One - 17 May 2022

9:00 am - 9:45 am EST Out of Industry Case Study: P&G’s Operational Excellence story – How we combine OPEX and DIGITAL to drive performance

Marc Winkelman - Global Director IWS Manufacturing Excellence, Procter & Gamble

P&G is widely regarded for its operational excellence capability. That capability helped the company to have a year-on-year results of cost saving, inventory reduction, service improvement, productivity gains and employee satisfaction. In this presentation, you will learn about the critical leadership actions to build and maintain the capabilities to achieve this level of performance AND how that helps to create the foundation to leverage digitization to advance that journey.

Key areas to be address include:

• What does P&G expect from her factories, and how do IWS helps each factory to deliver those expectations

• What are the critical actions you as leader can do to build the capability for these results and successful digitization

• How P&G links the development, implementation, and use of digital tools with the OPEX journey

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Marc Winkelman

Global Director IWS Manufacturing Excellence
Procter & Gamble

10:00 am - 10:45 am EST Is Your Electronic Batch Record Truly Complete?

Brian Curran - SVP of Manufacturing Excellence Customer Success, MasterControl

You might think you have a complete electronic batch record (EBR) system, but how do you know if it is truly complete? If you have paper documentation making its way into the process, or if you manually transfer data from one system to another, you do not have a complete EBR and are leaving yourself open to risk.  

 At every stage of manufacturing, whether production planning, manufacturing execution, quality control and quality assurance, or data management and analytics, your systems should be completely integrated, paperless, and exchange data without human error. If they aren’t, you are wasting precious time and resources.  

 A partially complete EBR system can only provide partial benefits, still leaving you open to the risks of poor data integrity, lack of visibility, inability to search for information, and incomplete datasets when it comes to decision-making. This session will illustrate the difference between a partial EBR and a fully connected EBR solution that enables smarter, faster manufacturing with immediate performance gains at every step. The best part, these solutions work for high-mix, low-volume lines, where traditional systems can be cost-prohibitive.  


This session will address:

• How to identify a complete EBR system

• Partially digital and disconnected systems are not efficient and increase risk

• Fully digitized batch records enable smarter, faster manufacturing so manufacturers can make immediate performance gains at every step

• Today’s technology is configurable to a variety of manufacturing scenarios



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Brian Curran

SVP of Manufacturing Excellence Customer Success
MasterControl

11:00 am - 11:45 am EST Adopting Automation in Fill/Finish of OSD to Increase Reliability and Reproducibility

Dave Berry - Head of Digital, MMIC

The advancement of automation, including robotics, is one area of progress for fill/finish processes. This session will address:

  • Strategic steps and a 101 of where to start when considering fill/finish operations of OSD on demand to GMP spec
  • What lessons have been learned when implementing a modularized approach to fill/finish automation
  • How to accommodate QP release
  • How modularization allows flexibility in terms of production capacity and product variety

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Dave Berry

Head of Digital
MMIC

12:00 pm - 12:45 pm EST FIRESIDE CHAT: How to deploy QbD and PAT from R&D into Manufacturing Processes

Sridevi Challa - Group Head - Formulation Development, Novartis, Sandoz Development Centre


-       Deploying QbD and PAT from R&D into Manufacturing practices

-       Utilizing data science, digital initiatives, and digital twins to support real-time analysis

-       Exploring the impact of AI and ML on processes using PAT tools 

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Sridevi Challa

Group Head - Formulation Development
Novartis, Sandoz Development Centre