2016 ISPE Annual Meeting & Expo

As you’re putting together your 2016 ISPE Annual Meeting & Expo education schedule, take a look at the sessions below to hear from the speakers on what knowledge you will gain from attending that session.

Facilities and Equipment

  • 101 – Building Information Modeling- Enabler for Project Team Collaboration and Lean Projects
    Tuesday, 20 September 11:00 – 12:30
    “We are under huge pressure to deliver our projects better, quicker and cheaper…this session will highlight not just how BIM and Lean must be proactively integrated to help achieve this but also how BIM generated data can now be used in the operation and maintenance of your new facility.”
    Mick Lyman, Director, PM Group

  • 104-Evolution of Facility Preventative Maintenance Program: Next Generation Design
    Sunday, 18 September 13:45 – 15:15
    “Your facility preventive maintenance program is almost surely over designed.  Attend this session to learn strategies about implementing a more efficient maintenance program  You will achieve productivity improvements that ultimately benefit both your firm and patients that rely on you.”
    Ryan Schad, PE, Consultant – Business Operations, Eli Lilly & Co.

  • 105 – New Directions in Biotech Facility Design
    Tuesday, 20 September 13:45 – 15:15
    “Among the biggest biotech facility projects ever. If not the biggest in their league. Large scale continuous bioprocessing. Large volume single use technology. Join the The New Directions in Biotech Facility Design session to find out.”
    Niels Guldager, Global Technology Partner,  NNE Pharmaplan

  • 106 – Tests on Rouging and Experiences Dealing with Rouging in Pharmaceutical Production (Part 1)  and 116 – Tests on Rouging and Experiences Dealing with Rouging in Pharmaceutical Production (Part 2)
    Monday, 19 September 11:00 – 12:30 (Part 1)
    Tuesday, 20 September 11:00 – 12:30 (Part 2)

    “Learn about the latest knowledge about the topic of Rouging!” “These sessions convey the state-of-the-art about Rouging!” “ROUGING – Demystification of a common, but rarely discussed issue in pharmaceutical industry!”
    Marc Vernier, CEO, Ateco Tobler AG

  • 109 – Aligning the Master Plan with the Business and Investment Plan – The Why, What, and How
    Monday, 19 September 13:45 – 15:15
    “In our world, it takes 4-7 years to get from concept to licensure on strategic projects.  Which means we have no time to waste and need to be investing in the right things for the business.  Master Planning is the only way to win.”
    Drew Johnston, Director, Capital Projects and Site Facilities Engineering, Bayer

  • 110 – The In’s and Outs of Critical Systems Sampling
    Monday, 19 September 13:45 – 15:15
    “Have you ever had an actionable result come back from sampling that turned out to be a false alarm?  Come to THIS session to find out the “why” and improve your operation’s and bottom line.”
    Brian Hagopian, CPIP, Chemist, Clear Water Consulting, Inc.

  • 111 – Facility of the Year (FOYA) Category Winners Part 1 and 115 – Facility of the Year (FOYA) Category Winners Part 2
    Monday, 19 September 13:45 – 15:15 (Part 1)
    Monday, 19 September 16:15 – 17:45 (Part 2)

    “The ISPE Facility of the Year Award, now in its 12th year,  is the leading global champion of pharmaceutical excellence, recognizing  state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies and project execution strategies  to deliver  a superior project, as well as reduce the cost of producing high-quality medicines.  Come listen to this year’s impressive international category winners as they present their projects and vie for the overall award to be announced on 9/20. A great collection of projects.”
    Dave DiProspero, Associate/Director of Pharmaceutical Process Technology, CRB

  • 112 – GMP Clinical Facilities- The Intersection of the University and Pharma
    Monday, 19 September 16:15 – 17:45
    “Our session is to discuss the past present and future intersection between academia and pharma bio and cGmps  manufacturing with case studies and discussions we Look for your input.”
    Terry Jacobs, AIA, Partner, JacobsWyper Architects

  • 113 – Energy and Water Sustainability in Your Facility
    Monday, 19 September 16:15 – 17:45
    “Hear some practical advice on modifications to reduce operating costs, and ways of implementing them.”
    Nick Haycocks, Senior Specialist QA, Amgen Inc.

  • 117 – OSD Manufacturing Facilities of the Future
    Tuesday, 20 September 11:00 – 12:30
    “This session provides delegates with an update on the latest achievements and developments in continuous manufacturing of solid dose pharmaceutical products. You will hear a case study of Jansen’s road to approval, how Patheon is setting the path for a contract manufacturer’s offering of continuous manufacturing services, and Rutger’s/C-SOPS’ vision of the path forward for continuous manufacturing.”
    Pär Almhem, President, ModWave

  • 118 – The Zero Shutdown Goal – Reducing and Eliminating Shutdowns
    Tuesday, 20 September 13:45 – 15:15
    “Maintenance of cGMP systems have regulatory implications that tend to drive decision makers to settle on a strategy that can be overly conservative resulting in a program with too many maintenance tasks rather than one that is optimized based on the evidence.  Routine shutdowns to conduct preventive maintenance is an example.  Are the cost of shutdowns, including the accompanying risk of failure that follows opening up a system for preventive maintenance, really worth it?”
    Richard Tree, Vice President Commissioning Agents, Inc.

  • 120 – Practical Application of Risk-Based C&Q
    Tuesday, 20 September 13:45 – 15:15
    “Hear real world examples of how QRM-based Commissioning and Qualification was executed in legacy and new facilities!”
    Mark Rezac, PE, Director Compliance, IPS

  • 121 – “Dancing Through Traffic”- Project Execution in Operating Plants
    Wednesday, 21 September 08:30 – 10:00
    “Successful retrofit projects require detailed choreography of every activity in order to maintain the production schedule and to limit risk of project activities colliding with the ongoing production all around them.  ‘Dancing Through Traffic’ should leave attendees with actionable information to execute projects that conclude with smooth, on-time return to service.”
    John Spohn, CPIP, Senior Project Manager, Hargrove Life Sciences

  • 123 – GMP or nonGMP Washers-Sterilizers? How to Choose?
    Wednesday, 21 September 10:15 – 11:45
    “Don’t miss experts Andre-Pierre Ghys, Marcel Dion and Matt Hofacre at the 2016 ISPE Annual Meeting & Expo on September 21.  If you have questions about the differences between a GMP or non-GMP Washers, Sterilizers or other equipment, this presentation is for you!”
    Marcel Dion, Director of Marketing, STERIS Corp.

  • 124 – Innovating Project Management – Focus on BioPharmaceutical Drug Delivery
    Wednesday, 21 September 10:15 – 11:45
    “Working on a Bio project or Program? Then you need to head down to session 124 where key industry speakers will highlight REAL issues and talk about how planning, benchmarking and risk management are supporting success.”
    Trish Melton, PhD, Managing Director, Mime Solutions Ltd.

  • 125 – How to Get to Know Critical Utilities in 30 Days
    Sunday, 18 September 12:00 – 13:30
    “Learning the critical attributes of Pharmaceutical Water and Steam systems can be overwhelming. This session will help you understand the critical attributes of water and steam systems from installation to distribution.”
    Brian Severson, Water Systems Engineer, Sage Products

Regulatory Compliance and Quality Systems

  • 201 – Application of Process Capability and Tools in the Pharmaceutical and Biotech Industries: Part 1 and 202-Application of Process Capability and Tools in the Pharmaceutical and Biotech Industries: Part 2
    Sunday, 18 September 12:00 – 13:30 (Part 1)
    Sunday, 18 September 13:45 – 15:15 (Part 2)

    “In this session, you will hear the perspectives of the FDA, a leading generic pharmaceutical company and a top 10 innovator biopharmaceutical company on how to best use process capabilities to achieve compliance and supply reliability. The ISPE process capability community of practice will also share the highlights of their work on this subject, including the interim results of an industry survey on process capability programs.”
    Philippe Cini, Group Vice President, Tunnell Consulting, Inc.

  • 203 – Clinical Relevance
    Monday, 19 September 11:00 – 12:30
    “This session will provide exciting scientific justifications describing clinical relevance of an in vitro product control strategy which has become an increasing regulatory focus for managing the lifecycle of a product.”
    Roger Nosal, PhD, Vice President & Head, Global Chemistry, Manufacturing & Controls, Pfizer Inc.

  • 204 – Demystifying the Knowledge Management Enabler of ICH Q10
    Monday, 19 September 13:45 – 15:15
    “Interested in how the industry is tacking the ICH Q10 enabler of Knowledge Management? Biogen will share techniques on capturing the “know-how” and “know-what” of technical product knowledge and Dr. Menezes will share an approach on leveraging “prior” knowledge preparing for ICH Q12 forthcoming guidance.  Our presenters will be joined by additional panel members to discuss knowledge management industry opportunities and questions.”
    Paige Kane, Director, Knowledge Management, Merck
  • 205 – Recent Regulatory Compliance Developments in China
    Monday, 19 September 16:15 – 17:45
    “This session on China is a must attend! – It will give professionals from multi-national companies the most up-to-date regulatory and compliance information: (1) China FDA’s overseas manufacturing site inspection; (2) regulatory challenges and opportunities for drug development in China; and (3) challenges in implementing 2015 Chinese Pharmacopeia.”
    Chi-Wan Chen, PhD, Executive Director, Pfizer Inc.

  • 211 – Quality Metrics Revisited – Measuring and Managing Quality from an Overall System Perspective
    Tuesday, 20 September 13:45 – 15:15
    “Learn what a system-based perspective on quality metrics does include. Get an understanding about the contribution of quality and quality culture to overall performance.”
    Thomas Friedli, PhD, Director of Institute of Technology Management, University of St. Gallen

Product Development and Production Systems

  • 302 – Single-Use Technology Assessment & Implementation via Retrofit of a Clinical Manufacturing Facility
    Sunday, 18 September 13:45 – 15:15
    “Understand the qualitative and quantitative factors in the selection of a 2000L Single-Use Bioreactor platform for a Global “Manufacturing Supply Strategy”.  Retrofit of an existing multiproduct GMP Clinical Manufacturing facility to implement this technology, while maintaining other GMP operations, presented a variety of challenges that will be shared with attendees.”
    Stephan Orichowskij, PE, CPIP, Senior Director Process Technology, Hargrove Life Sciences

  • 303 – Continuous OSD Manufacturing Overview
    Monday, 19 September 11:00 – 12:30
    “Broaden your OSD-Continuous Manufacturing knowledge with an overview of the technology including a real example and a panel discussion with leaders in this subject matter.”
    Michael Rooney, Sr. Technology Manager OSD, Jacobs Engineering Group Inc.

  • 305 – Real Time Release Testing – How IT Systems Support the Process Control Strategy
    Monday, 19 September 16:15 – 17:45
    “The ICH Guidelines are now accepted and established in the industry. Learn from industry leaders how the ICH Control Strategy is transformed into the PRODUCTION Control Strategy by case studies including modern IT architectures to support best in class production processes in Batch as well as in Continuous Production Processes.”
    Christian Wölbeling, Senior Director Global Accounts, Werum IT Solutions GmbH

  • 308 – Aseptic Technology & GMP Quality Systems for Compounding Industry
    Tuesday, 20 September 13:45 – 15:15
    “Is your small scale manufacturing facility living on borrowed time?  This program is a “must-attend” to track the evolution of Aseptic Technology and GMP Quality Systems for 503B pharmacies and small scale manufacturing.  Come hear “lessons learned” case studies from real-world projects to identify risks and solutions how you can balance capabilities and regulatory expectations.  Network and learn insights and known missteps from others.”
    Hite Baker, Principal Process Engineer, DME

Information Systems

  • Information Systems Track
    “Technology continues to advance, and data is still king. Be sure to stay compliant!”
    Eric Staib, Executive Director Quality Assurance, PRA Health Sciences

  • Data Integrity Sessions
    “Data Integrity is the hottest regulatory topic today – Learn more about how it applies to you and your company and what ISPE and GAMP® are doing to help you address the expectations.”
    Mike Rutherford, Consultant – Laboratory and Quality Systems, Eli Lilly & Co. and Annual Meeting Education Chair

  • 405 – A Holistic Approach to Data Integrity
    Monday, 19 September 16:15 – 17:45
    “Achieving data integrity takes more than just passwords and an audit trail. This sessions highlights the impact of people and culture on your data, and will provide you an understanding of the management and behavioral principles needed to attain true data integrity within your organization.”
    Charlie Wakeham, Informatics CSV Consultant, Waters Australia

End-to-End Supply Chain Management

  • 501 – The Peoples Court – Equipment Supplier Management Debate Goes To Court
    Sunday, 18 September 12:00 – 13:30
    “Operating company and equipment supplier representatives come face-to-face in a court room style debate.  Each side will vigorously argue their perspective as to how the other party negatively impacts the process hoping to win a final ruling in their favor by a jury of their peers.”
    Jim McGlade, Science Market Leader, BHDP Architecture

  • 506 – Best Practices in Operations and Supply Chain Management
    Tuesday, 20 September 11:00 – 12:30
    “Our marketplace is becoming more global, complex, and competitive with drug costs outpacing inflation, so Operations Management needs to be exceptional to drive efficiencies while maintaining quality.  Surprisingly, the OM survey shows maturity levels lower than previously thought.  We are going to present the results and talk about how the new guide can help you move in the right direction.”
    James Curry, Owner/CEO, OpStat Group Inc.

  • 507 – Countdown to Serialization: Exchanging Data End to End through the Supply Chain
    Tuesday, 20 September 13:45 – 15:15
    “The manufacturer’s deadline to comply with the Drug Supply Chain Security Act (DSCSA) is closing in.  Come hear about some of the lessons learned from current implementations and what you can do to now to prevent missing the deadline.”
    Steve Peterson, Principal, Peterson Group, LLC

Innovation Forum

  • 601 – Global Regulatory and Industry Opportunity
    Sunday, 18 September 12:00 – 13:30
    “Implementation of emerging technologies in pharmaceutical industry is becoming reality! Please come to hear all the good stories…”
    Sau (Larry) Lee, PhD, Associate Director for Science Chair, OPQ Emerging Technology Team Office of Pharmaceutical Quality, FDA

  • 605 – Control Strategy
    Monday, 19 September 16:15 – 17:45
    “This session is a must if you are interested to learn about innovative ways to improve manufacturing agility, costs, productivity, and process capability. Come and learn about the latest trends in Predictive and Adaptive control strategies.”
    Mojgan Moshgbar,  Director/Team Leader, Pfizer Inc.

Women in Pharma

  • 700 – Women in Pharma: How did we get here? and 701-Women in Pharma: Panel Discussion
    Monday, 19 September 11:00 – 12:30 (700)
    Monday, 19 September 13:45 – 15:15 (701)

    “This September in Atlanta, a group of women who are highly committed to their families, their social interactions and their jobs will share with us their stories. Please join our panel of distinguished senior women professionals as they discuss their journey in the pharmaceutical industry.”
    Charlotte Enghave Fruergaard, PhD, Partner, Process Technology Consulting, NNE

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