2ND ANNUAL PHARMACEUTICAL MANUFACTURING EXECUTION SYSTEMS CONFERENCE

MAY 22-23, 2017 | SAN ANTONIO, TX
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DAY TWO | TUESDAY, MAY 23

7:30 REGISTRATION & WELCOME COFFEE

7:50 CHAIRPERSON’S OPENING REMARKS
Baha Korkmaz, Senior VP, Operations, North America
ENTERPRISE SYSTEM PARTNERS GLOBAL CORPORATION

8:00 CO-PRESENTATION: 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

Steve Giles, PGS & Finance BT, Pharma Ops & Mfg. Solutions, PFIZER

 

8:45 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

SESSION MODERATOR:
Jairus Martin, Senior Program Analyst, BAUSCH + LOMB

 

9:30 COFFEE & NETWORKING BREAK

 

10:00 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 MODERATORS:
Denny Catacora, Senior Engineer, Manufacturing Execution Systems, CSL BEHRING

Josh Fritz, Program Analyst, SHIRE

 

10:45 MES PREPARATION AS THE KEY TO SUCCESS
Learn about a proven and mature methodology to develop a conceptual solution architecture designed to meet the business objectives of the pharma/biotech manufacturing business. Our approach involves a strategy development methodology that brings focus and enables superior solution architecture tailored for Manufacturing Systems solutions, S95, and S88 standards. The key benefit of this methodology is effective alignment of business and technology.

  • Develop a prioritized capital project planning roadmap to meet business objectives.
  • Strategic Technology Management process for MES Applications for IT Enterprise Architecture.
  • Discover a holistic visual tool that enables harmony between all departments stakeholders.

Gilad Langer, Director of Automation & MIS, NNE

 

11:30 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

PANELISTS:
Jerry Gonzalez, BBRAUN

Ivan Cirino, ETHICON

Elton Ramos, SHIRE

 

12:15 LUNCHEON FOR ALL ATTENDEES, SPEAKERS & SPONSORS

 

1:15 CASE STUDY: OPERATING A MES ROLLOUT AT MULTIPLE SITES & LOCATIONS

  • Identifying unique organizational challenges from site to site
  • Standardizing multiple implementations on different platforms
  • Simplify operations to be designed & re-used without modifications

Frank O’Loughlin, MES Subject Matter Expert, Formerly with AMGEN

 

2:00 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

MODERATOR:
James O’Brien, ZENITH TECHNOLOGIES

PANELISTS:
Matthew Iwema, ELI LILLY

Christian Berg, GENENTECH

Jerry Gonzalez, B.BRAUN

 

2:45 MINIMIZING RECIPES REQUIRED FOR MANUFACTURING EXECUTION SYSTEMS

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

Jordan Croteau, Sr. Engineer, Execution Systems, BIOGEN

 

3:30 CLOSING REMARKS & CONFERENCE CONCLUSION

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