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2nd Annual Pharmaceutical Manufacturing Execution Systems Conference

May 22-23, 2017 | San Antonio, TX Download AgendaRegister Now

DAY TWO | TUESDAY, MAY 23

8:30 REGISTRATION AND WELCOME COFFEE

8:50 CHAIRPERSON’S OPENING REMARKS
Baha Korkmaz, Senior VP, Operations, North America
ENTERPRISE SYSTEM PARTNERS GLOBAL CORPORATION

9: 00 DEPLOYMENT METHODOLOGIES FOR LAUNCHING A SUCCESSFUL MANUFACTURING EXECUTION SYSTEM

  • Utilizing the concept of core solution
  • Expanding system functionality based on best practice and operational excellence
  • Use of standards & EBR deployment for centralized recipes
  • Connectivity to DCS/Automation
  • Evergreen strategy

Martin Dittmer, Product Manager
ROCKWELL AUTOMATION

 

9:45 GROUP DISCUSSION: APPROACHES TO EFFECTIVELY MANAGE MANUFACTURING EXECUTION SYSTEM LIFE CYCLE

  • Recognizing the MES’s lifespan
  • Handling multiple lifecycles in a single MES
    • MES software
    • MES equipment
    • MES vendor tools
  • MES lifecycle management costs

Jairus Martin, Senior Program Analyst
BAUSCH + LOMB

 

10:30 COFFEE & NETWORKING BREAK

 

11:00 GROUP DISCUSSION: VALIDATION PROCESS & CRITERIA FOR PHARMACEUTICAL MANUFACTURING EXECUTION SYSTEMS
When implementing and upgrading a MES, manufacturers must validate the overall system itself, in addition to on-going control strategies to meet compliance with authority requirements and prepare for manufacturing facility inspections. To ensure the most appropriate validation of a MES design, it is essential to have a well-defined strategy, based on quality standard operating procedures (SOPs) and further detailed in an approved quality assurance plan (QAP). Understanding the technological complexity of MES increases the need for more rigorous review, testing, and oversight of the MES validation process.

  • Considerations & controls necessary for validation & compliance
  • Determining standards for testing external systems for potential integration
  • Validation of batch records for new manufacturing areas

Session Moderator:

Denny Catacora, Senior Engineer, Manufacturing Execution Systems
CSL BEHRING

 

11:45 PANEL DISCUSSION: DETERMINING THE VALUE & NEED FOR CONTINUOUS MES UPGRADES
With the plethora of MES-related software and IT tool upgrades released every month, manufacturing executives are required to determine the need for an upgrade as well as carefully supervise the shift through change control procedures. In theory, operations must not slow down and furthermore, the MES must remain compliant and efficient during the transition period. Manufacturing executives are at times un­sure whether to launch an upgrade to a system all while maintaining high production rates of pristine quality or determine if the system can remain in current form.

  • Benefits in staying up to date vs. stable in systems versions
  • Approaches for effectively managing IT software upgrades
    • Lifecycle of the equipment itself
    • Incentives in changing software versions
  • Upgrading legacy systems to new systems
  • Cost-benefit analysis for upgrading MES

Session Moderator:

Martin Dittmer, ROCKWELL AUTOMATION

Panelist:

Christoph Lebl, GENENTECH

Jerry Gonzalez, BBRAUN

12:30 LUNCHEON FOR ALL ATTENDEES, SPEAKERS & SPONSORS

1:45 PANEL DISCUSSION: BUILDING A SUPPORT MODEL FOR MES LARGE SCALE INVESTMENTS

  • Importance of support model design in a 24/7 operating system
  • Debating cost-efficiency in MES support models
  • Balance between outsourcing & employee workforce
  • Analysis of common support model pitfalls & lessons learned

Panelist:

Matthew Iwema, ELI LILLY

Christian Berg, GENENTECH

 

2:30 MINIMIZING RECIPES REQUIRED FOR MANUFACTURING EXECUTION SYSTEMS

  • Defining the value of recipe parameters for different systems
  • Utilizing MES system recipes for product variations
  • Comprehending the concept around object based recipes
  • Managing data to minimize appropriate recipes required

Jordan Croteau, Sr. Engineer, Automation
BIOGEN

 

3:15 CLOSING REMARKS & CONFERENCE CONCLUSION

 

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