3rd Annual Pharmaceutical Manufacturing Execution Systems Conference

May 23-24, 2018 | Rosemont, IL

Lowes Chicago O’hare Hotel

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DAY ONE | WEDNESDAY, MAY 23

7:30 Registration & Welcome Coffee

8:15 Chairperson’s Opening Remarks
Alp Unal, CEO, North and Central America, ENTERPRISE SYSTEM PARTNERS

8:30 OPENING ICE BREAKER: SHARING MES SELECTION CRITERIA KEY CONSIDERATIONS
This interactive ice breaker will open the event with an opportunity for all participants to move around the conference room with the goal of meeting other delegates and engaging in swift discussions. The audience is encouraged to briefly exchange perspectives on key factors to consider when building a MES selection criteria, including identification of specific manufacturing needs, ease of system integration and end-user usability. Furthermore, participants in this warm-up session are also given the opportunity to directly build contacts with industry peers, kicking off the event networking platform.

 

9:00 IMPLEMENTATION CASE STUDIES: PRACTICAL INSIGHT INTO MES INTEGRATION
Through thoughtful analysis of the project timeline and necessary support, synchronization of a MES with other systems such as control engineering, manufacturing management or ERP allows for increased control and visibility of the production process including material consumption, cycle times and operating efficiencies as well as system maintenance needs. Most commonly, MES engineers face difficulties in creating a bridge between manufacturing systems to ensure communicability and prevent conflicts that hinder the manufacturing continuum. Focusing on peers’ direct experience, insights into the practical aspects of initiating system integration and leading the project to successful completion will be shared through short and targeted case studies.

BIOGEN CASE STUDY
Dave Hinkler, Manager, Business Analysis, BIOGEN

Stéphane Dattenny, Principal IT Architect, BIOGEN

 

9:45 Coffee & Networking Break

 

10:15 ROCHE/GENENTECH BIOLOGICS TECH TRANSFER TOOL IMPLEMENTATION:

  • Assessing current business challenges
  • Determining appropriate business solution
  • Expected business result

Jody Logan, Assoc. Dir. Manufacturing BioProcess, GENENTECH

 

11:00 CHALLENGES OF MES IN MERGERS AND ACQUISITIONS AND EMBRACE NEW TECHNOLOGY

  • Understand budgetary concerns
  • Determine the scope of implementation
  • Examine ERP and current process – steps of Level 3 and Level 2 migration
  • Discuss how to prepare and overcome these challenges
  • Use of new technology with existing architecture

Deepesh Rathore, Senior Manager IT, TEVA

 

11:45 PANEL DISCUSSION: STRATEGIES TO OVERCOME CHALLENGES IN MES INTEGRATION

  • Synchronizing MES with existing systems
  • Developing end-user trainings & support
  • Ensuring system software validation
  • Creation of engineering integration standards

Daniel Trivino, Manufacturing Executing Systems (MES) Engineer, CSL BEHRING

Jamie Hnaihen, Manager, Supply Chain, ADELLO BIOLOGICS

Srinivas Adusumilli, Lead Automation Engineer, GE HEALTHCARE

Bob Schiros, Syncade Sales Director, Americas, EMERSON AUTOMATION SOLUTIONS

 

12:30 Luncheon for all Participants

 

1:45 TAKING A PROACTIVE APPROACH TO SYSTEM & SOFTWARE VALIDATION
When implementing, and integrating a MES with existing support systems, system-wide validation is required for manufacturers to ensure efficacy and compliance. To guarantee a successful validation, manufacturers must develop a well-defined strategy that thoroughly takes into account system-specific configurations, dependent on vendor software and distinct manufacturing processes. Further, proactively conducting system and software validation time and cost analysis assists in decreasing commonly lengthy and budget-consuming validation efforts, enabling a swift launch of the validated MES.

  • Interpreting FDA guidance based on system configuration
  • Engaging end-users in the MES validation plan
  • Defining realistic time & cost for validation
  • Identifying methods to expedite MES validation
  • Implementing a robust validation project roadmap

Brian DiVasta, CSV Compliance Manage, SANOFI

 

2:45 REAL LIFE EXPERIENCES IN MULTI SITE MES ROLL OUTS – PAST PRESENT AND FUTURE

  • Evolution of MES – Moving towards Global Programs
  • Site vs Core deployment challenges and opportunities
  • Teaming up for success – Organizing stakeholders to achieve maximum efficiency

Alp Unal, CEO, North and Central America, ENTERPRISE SYSTEM PARTNERS

 

3:30 Coffee & Networking Break

 

4:00 SMALL GROUP DISCUSSIONS: DEVELOPING A MES SUPPORT TEAM FROM THE GROUND UP

  • Ideal support team based on company-specific needs
  • Overcoming challenges in 24/7 ongoing support
  • Balance between support outsourcing & insourcing

Daniel Trivino, Manufacturing Executing Systems (MES) Engineer, CSL BEHRING

Jamie Hnaihen, Manager, Supply Chain, ADELLO BIOLOGICS

Matt Gresh, MES Base Business Lead, JANSSEN

 

4:45 SMALL GROUP DISCUSSIONS: REALISTIC APPROACH TO MES STANDARDIZATION OPPORTUNITIES

  • Challenges & benefits in MES standardization within:
    • One manufacturing plant including multiple products
    • One corporation including multiple manufacturing sites
    • The overall pharmaceutical industry
  • Standardization complexity in global manufacturing sites
  • Forecasting the future of MES standardization

Jordan Croteau, Senior Engineer, Execution Systems, BIOGEN

Todd Lybrook, Portfolio Director, SIEMENS INDUSTRY

 

5:30 Closing Remarks & Day 1 Conclusion

 

5:35 Cocktail Hour for all Participants

 

7:00 CONTINUED NETWORKING: FACILITATED GROUP DINNERS

With the immense value in peer-to-peer interaction and experience sharing, we wish to provide attendees with an opportunity to continue networking after the first day of the conference. Q1 Productions will arrange dinner reservations at local restaurants close to the conference hotel for those interested in joining a group of fellow participants for dinner on Wednesday May 23rd. Please note that dinner expenses must be covered by each participant individually.

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