3rd Annual Manufacturing Execution Systems

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“This conference provided an excellent forum for networking and for discussing the key challenges and technologies driving the MES industry today.” — 2007 Attendee, Michael Asher, MES Lead, GlaxoSmithKline MAIN CONFERENCE Day One — Tuesday, August 5, 2008 12:00 Main Conference Registration 1:15 Chairman’s Opening Remarks Dan Matlis, President, Axendia Achieve Optimal Production and Manufacturing Quality 1:30 How Life Science Manufacturers Are Attaining Operational Excellence Pharmaceutical, biotech and medical device manufacturers face substantial pressures. To compete and succeed, the industry must decrease costs, achieve operational improvements and all the while ensure robust regulatory compliance. An efficient manufacturer must collaborate between the enterprise and plant floor across order management / batch execution; inventory / material, line / equipment, and personnel planning; while improving quality control and assurance for review, approval, and release. This is made even more challenging with the need to have manufacture automation and processes that can operate in a multi-product environment rather than the traditional one process for one product design. The need to collapse Levels 2 and 3 of the S95 model is profound. This session illustrates the shifting dynamics driving this need and provides insight into the implications on work practices and applied technology required to deliver this efficiency. • Industry challenges in operations and compliance • Implications of a ISA-S95-based approach • Solutions for collaboration in the plant • Strategies for increased consistency and “Right First Time” metrics • Approaches for integrating across systems and facilities John Blanchard, Principal Analyst, ARC Advisory Group 2:15 Achieving Quality by Design in Pharmaceutical Manufacturing — An Update on PAT/QbD Regulatory Expectations and Submissions The FDA has challenged the industry to achieve a level of process understanding that is commensurate with a high level of control around process variability and product quality in “real time”. This emphasis on “Quality by Design” is making it increasingly important for life science manufacturers to invest early in the product life cycle during process development and to build a sound basis for a “control space”. This session provides an update on FDA regulations related to PAT and QbD and also discusses considerations for Design Space development in QbD. • Update on FDA practices and expectations for PAT and QbD • Control strategy and use of in-process and final product testing 4 Panel Discussion photo by: Photolink / Getty Images • Identifying challenges including: * defining Design Space * identifying critical process parameters * integrating control strategy * reporting requirements for changes within the Design Space • Top reasons for drug quality defects • FDA guidance on the horizon Richard P. Poska, R.Ph., Director, Global Pharmaceutical Regulatory Affairs, CMC-GPRD Small Molecule Support, Abbott 3:00 Networking and Refreshment Break 3:30 Emerging Manufacturing Control Systems for Improved Operational Performance This session illustrates how MCS (Manufacturing Control Systems) can achieve seamless and synchronized system architecture to support electronic batch records and exception reporting for automation and production management. • What is an MCS (Manufacturing Control System) • Benefits of an integrated system • Challenges of MES and batch automation • Standards and technology — Current practice • Vision for future systems Carey Clements, Life Sciences MES Product Manager, Honeywell 4:15 Industry Directions for MES Adoption, Integration and Standards This panel discussion convenes industry MES leaders and trailblazers to discuss the state of MES adoption, challenges in achieving integration and the future of standards adoption. • Views on the level of MES sophistication to date • New enhancements and advancements in systems and processes • Most problematic challenges in achieving MES interoperability and enterprise-wide integration • Outlook for standards adoption and the need for further standardization Moderator: Tony Fenn, Principal Engineer, Bristol-Myers Squibb Panelists: Paul Brandenburg, Team Lead, Site Execution Systems, Eli Lilly & Co Michael Asher, Control Engineer, GlaxoSmithKline Keith T. Evans, Biotech OpU MES Focal Point, TO&PS BSP, Wyeth Pharmaceuticals Cathal Strain, Senior Director and Team Leader, API Automation, Pfizer Inc 5:15 Close of Day One 5:15-6:15 Networking, Wine & Cheese Reception Join colleagues and friends in a relaxed setting.
Day Two — Wednesday, August 6, 2008 7:30 Continental Breakfast 8:00 Chairman’s Review of Day One Dan Matlis, President, Axendia MES Implementation Strategy and Lean/MES Case Studies 8:15 How Device, Diagnostic and Biotech Manufacturers Are Improving Performance with Real-Time, Predictive and Actionable Intelligence In the face of increasing competition, frequent new product introductions and high customer expectations, medical device, diagnostic and biotech manufacturers are turning to Manufacturing Execution Systems to help with data acquisition and process enforcement. Leveraging the data, manufacturers are advancing to the next level of quality and performance. This panel convenes industry professionals to discuss how they use real-time, predictive and actionable manufacturing intelligence to improve quality, address issues at the source and accelerate new product introductions. Moderator: Dan Matlis, President, Axendia Panelists: John Oakley, Chief Architect, Manufacturing Systems, Applied Biosystems Karim Lokas, Vice President of Product Strategy, Camstar Rey Medina, Director of Manufacturing Systems, Johnson & Johnson Cordis Gilad Langer, Senior Product Manager, Camstar Marc White, MES Program Director, Boston Scientific (Invited) Panel Discussion 9:00 Laying the MES Groundwork through ISA 88 Process Mapping and Batch Record Standardization — Shire's Story Prior to putting the first foot in the “MES waters”, it is critical that life science organizations plan and execute the necessary pre-MES groundwork. Ultimate MES success and measurable results depend upon the early establishment of a strong MES foundation. This session discusses the steps taken at Shire to establish a good foundation for an MES project, scheduled to kick-off in mid-2008. Learn how Shire walked through the planning, process mapping and standardization necessary for MES success. • ISA 88 Mapping — How ISA 88 mapping probed through four levels Case Study • Leveraging ISA 88 process mapping to generalize maps configurable for any future products • Batch Record Standardization — How batch records were first standardized on paper before going electronic Samantha Krebs, Senior Process Improvement Technical Writer, Shire Pharmaceuticals, Inc. 9:40 Advancing from a Home-Grown Legacy System for Traceability of Device History Records — Key Considerations, Objectives and Next Steps This case study shares the background, business objectives and considerations taken in mapping out the plan for advancing Guidant’s home-grown legacy system to a full-featured MES. As with any medical device organization, traceability of device history records is paramount. Medical device manufacturers also need automated and cost-effective solutions with capabilities to address regulatory requirements, complex manufacturing needs and optimized throughput and quality. In this session, learn the considerations and decision-making steps taken within Boston Scientific to adapt and advance their manufacturing organization. • Home-grown solution for traceability of Device History Records • Operational improvements made and underway • Assessing the current state of the legacy system and manufacturing quality systems Case Study • Facing the build or buy decision — Key considerations • Steps needed to advance from an antiquated traceability system to a full-functioning MES • Conducting the “to-be” analysis and examining next steps • Lessons learned Tom Litterer, Manager, Boston Scientific Tracy McMorrow, Manager, Boston Scientific 10:20 Networking and Refreshment Break 10:50 Embarking on a Pilot and Phased Roll-Out MES Approach at Bayer's Berkeley Site — How MES is Taking Form within Various Production Suites Bayer Healthcare's Berkeley site is a biotech facility embarking on an exciting MES roll-out. This case study discusses the key steps undertaken in planning for MES implementation, the approach for MES implementation and the experience to date within the various production sites using MES. • Review of Bayer healthcare’s global approach and the unique approach taken within the Berkeley facility • Considerations in choosing an MES supplier Case Study • The pilot approach — How this works as a phased roll-out for MES • Experiences to date and lessons learned Andreas Dankelmann, Project Manager, Organization and Information, Bayer HealthCare Case Study Photos by: Getty Images To Register Call Toll Free 800-817-8601 (781-939-2438 outside the U.S.) or Fax 781-939-2490. Register on our website at www.cbinet.com 5
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3rd Annual Manufacturing Execution Systems

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