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 23RD

7:00 Registration & Welcome Coffee

7:45 Chairperson’s Opening Remarks

8:00 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.

 

8:30 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

 

9:15 BREAKOUT DISCUSSIONS: SHARING KNOWLEDGE & EXPERIENCE IN EVOLVING MES CHALLENGES
During this interactive session, executives will gather in small groups to discuss common areas of interest. This peer-to-peer learning environment, allowing for exchange of strategies and lessons learned will enable individuals to understand how other manufacturers overcome similar challenges through sharing of perspectives and real-life experiences. Each topic will be moderated by a subject matter expert, who will report key findings to the rest of the audience at the end of the session, maximizing all participants’ number of key takeaways.

Jack Shum, System Engineer, ORTHO CLINICAL DIAGNOSTICS *Pending final approval

 

10:00 Coffee & Networking Break

 

10:30 ROCHE/GENENTECH BIOLOGICS TECH TRANSFER TOOL IMPLEMENTATION:

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

Frederick Johnson, Sr. Mng. IT – Manufacturing, Engineering & CMO Applications, GENENTECH

Jackson Zhou, Project Manager, GENENTECH

11:15 TEVA CASE STUDY
Deepesh Rathore, Senior Manager IT, TEVA

 

12:00 Luncheon for all speakers, sponsors & delegates

 

1:00 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

 

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, Principal Validation Engineer, GENZYME

 

2:45 Coffee & Networking Break

 

3:15 REAL LIFE EXPERIENCES IN MULTI SITE MES ROLL OUTS – PAST PRESENT AND FUTURE

  • Moving towards Global Programs – Maturity curve and evolution MES Programs and stakeholders
  • Site vs Core deployment challenges and opportunities
  • Central vs Distributed teams – Organizing stakeholders to achieve maximum efficiency in MES projects.

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

 

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

 

4:15 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

Rey Ramos, MES Business Process Lead, JOHNSON & JOHNSON

 

5:30 Closing Remarks & End of Day 1

 

6:30 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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