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2nd Annual Pharmaceutical Manufacturing Execution Systems Conference

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

DAY ONE | MONDAY, MAY 22

8:00 REGISTRATION AND WELCOME COFFEE

8:50 CHAIRPERSON’S OPENING REMARKS

9:00 GROUP DISCUSSION: MES 101: FIRST STEPS INTO PHARMACEUTICAL MES SYSTEM SELECTION, CUSTOMIZATION & IMPLEMENTATION
Many pharmaceutical manufacturing corporations are currently considering shifting towards the utilization of a Manufacturing Execution System (MES) to enhance production management in addition to decreasing overall production facility and processes costs. While benefits in implementing a MES are numerous, the first steps into the new structure require careful attention to many details such as which software and technological platform will best fit specific manufacturing needs, as well as how to articulate and tailor the process to guarantee maximum ROI. Further, manufacturing executives must ensure a smooth transition to the new process in 24/7 facilities, necessitating forward planning and organizing. Through experience sharing, this 101 section will provide participants interested in understanding more about the first steps into MES implementation with a unique opportunity to gain insight into varied perspectives from peers in the pharmaceutical industry who will share practical approaches for implementing MES for the first time and lessons learned.

  • Selecting appropriate MES & securing corporate buy-in
  • Addressing prerequisites for implementation strategy
  • Outlining manufacturing system selection process
    • Appropriate tools to customize & tailor MES
    • Standardizing & deploying MES across organizations
  • Practical insight into common MES implementation pitfalls

Session Moderators:

Pascal Lim, Director Operations, Business Solutions
CEPHEID

Dan Ginn, Senior Business Solutions Analyst
CEPHEID

 

9:45 KEYNOTE PANEL: CRITERIA FOR HIGH QUALITY MES IMPLEMENTATION

  • Assessing MES readiness & plant performance strategies
  • Defining & agreeing to an appropriate MES business scope
  • Engaging stakeholders to define business objectives & drivers
  • Planning for successful implementation & sustainment

Panelist:

Andy Clyne, AMGEN

Joe Barone, 3M

 

10:30 COFFEE & NETWORKING BREAK

 

11: 00 CLARIFYING THE FDA DATA INTEGRITY DRAFT GUIDANCE & PREPARING FOR IMPLEMENTATION
In April 2016, the FDA released a draft guidance addressing data in­tegrity for manufacturers through the current good manufacturing practice (cGMP), in addition to providing recommendations for validating computer systems in manufacturing operations. These requirements involve developing and implementing highly technical features within the MES to validate data accuracy as well as increase data set security from one system to another. In order to proactively prepare for implementation, MES executives must ensure a thorough understanding of the guidance’s requirements, and how to tailor compliance strategies specific to varying systems.

PART 1: ROAD SHOW: VENDOR PERSPECTIVE

  • Remaining abreast of the FDA data integrity guidance
  • Common tools used to fulfill data integrity expectations
  • Upcoming technology & solutions used for data interpretation

Welf Ludwig, Sales Manager
WERUM

11:30 PART 2: INDUSTRY PERSPECTIVE

  • Interpretation of the draft guidance & application to sites
  • Identifying a clear definition of data integrity
  • Interaction with FDA & lessons learned

Brian DiVasta, Principal Validation Engineer
GENZYME

 

12:00 PART 3: COMPLIANCE PERSPECTIVE:

  • Analysis of the draft guidance & methods for compliance
  • Identifying MES gaps in light of the draft guidance
  • Practical steps & lessons learned for compliance

James Johnson, Partner
HOGAN LOVELLS

12:30 LUNCHEON FOR ALL ATTENDEES, SPEAKERS & SPONSORS

1:45 SYSTEM INTEGRATOR PERSPECTIVE: BEST APPROACHES & LESSONS LEARNED FOR MES INTEGRATION STRATEGIES
With the high level of costs involved in manufacturing operation systems implementation and complexity in incorporating a new process within a multiple-layered setting, pharmaceutical manufacturers must carefully plan and budget for MES integration. As a result, manufacturing teams are integrating control systems to allow for key business drivers such as reduced product cycle time and improved means of efficiency. In addition, as the architecture of a MES varies from one company to another, the industry is in need of clarification and practical insight into appropriate control systems selection criteria.

  • Outlining S95’s control systems hierarchy & applications
  • Interpretation of the 4 levels for system controls
    • Defining the high functionality of level 2 process control
    • Methods & analytics for connecting to an ERP system
  • Selecting a control system best suited for specific MES

Baha Korkmaz, Senior VP, Operations, North America
ENTERPRISE SYSTEM PARTNERS GLOBAL CORPORATION

 

2:30 PANEL DISCUSSION: PROS & CONS OF INTEGRATING MES IN EXISTING CONTROL SYSTEMS

  • Approaches for developing & designing system architecture
  • Utilizing technology & data to integrate control systems
  • Overview of successful end to end ERP, MES & PCS implementations
  • Corporate challenges faced with integration strategies

Panelist:

Elton Ramos, SHIRE

Ravikiran Medandravu, PMP, GENENTECH

Dakota White, ASTRAZENECA

 

3:15 COFFEE & NETWORKING BREAK

 

3:45 ALIGNING CUSTOMER EXPECTATIONS TO DELIVER SUCCESSFUL MES
Organizations are always chasing process improvement.  Internal customers have an insatiable appetite for continuous optimization of process control systems under ever shortening timelines. Unrealistic customer demands place a crushing burden on system administrators, creating an environment of unfulfilled expectations, cross-functional distrust, and weariness to pursue change.  Genentech’s Hillsboro facility has successfully used a simple framework for aligning customer expectations and priorities in order to deliver meaningful changes in a way that fosters trust and creates a sustainable environment for process improvement.

  • Align expectations regarding time, resources, and effort
  • Implement robust problem solving and options analysis.
  • Keeping system administrators and system users aligned

Christian Berg, Automation Manager, Manufacturing Execution Systems
GENENTECH

 

4:30 INTEGRATING PRINCIPLE SYSTEM WITH MANUFACTURING EXECUTION SYSTEM

  • Best approaches for developing system architecture
  • Recognizing integration challenges & approaches for overcoming challenges
  • Optimizing MES with principle system & corporate challenges faced with integration

Subodh Joshi, Senior Principle Engineer
SHIRE

 

5:15 CLOSING REMARKS & DAY 1 CONCLUSION

 

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