2014 ISPE Aseptic Conference

Schedule-at-a-Glance

Monday, 24 February
09:00 - 09:10 Welcome and Introductions
09:10 - 10:20 Keynote Presentations
10:20 - 10:30 Question/Answer Opportunity
    10:30 - 11:00 Networking Break
    11:00 - 11:05 Housekeeping and Intros
    • Leader: Ryan Hawkins, VP Ops - Chief Operating Officer, Cook Pharmica, LLC, USA
    11:00 - 11:05 Housekeeping and Intros
    • Leader: Joerg Zimmermann, Dir Process Dev Implementation, Vetter Pharma Fertigung GmbH Co KG, Germany
    11:05 - 11:45 Applying Lean Principles to Parenteral Clinical Supply Manufacture
    • Christine Martin, Ph.D., Compliance-Visual Inspection, AbbVie Deutschland GmbH & Co. KG, Germany
    11:05 - 11:45 Green Barrier Systems? Energy Consumption Comparison of RABS and Isolator
    11:45 - 12:25 Isolation-Based Sterile Facilities: A Comparison of Conventional Stainless-Steel versus Single-Use-Disposable Technology Implementation
    • Hite Baker, Principal Process Engineer, DME Alliance Engineering Consultants, USA
    11:45 - 12:30 Patient Centric Supply Chain
    12:25 - 12:30 Discussion Group Topics & FDA Questions
    • Leader: Ryan Hawkins, VP Ops - Chief Operating Officer, Cook Pharmica, LLC, USA
    12:30 - 13:30 Lunch
    13:30 - 14:15 Trends of Barrier Technology in China and Japan
    13:30 - 14:15 Challenges in Filling Live Virus Vaccines
    • Michael Faia, Associate Dir, Facilities & Eng, AstraZeneca, USA
    14:15 - 15:00 Challenges on Physical Container Closure Integrity Testing of Combination Product for Therapeutic Proteins
    14:15 - 15:00 Flexible Isolator Filling Line
    • Brian Greven, Associate Director, Engineering Projects, Boehringer-Ingelheim, USA
    15:00 - 15:30 Networking Break
    15:30 - 16:15 Isolator concept for the filling of cytotoxic drugs
    • Inga Roswadowski, Process Engineer, Syringe Filling, Oncotech Pharma Production GmbH, Germany
    15:30 - 16:15 Production Challenges and Benefits of a Fill-Finish Isolator
    • Blair Tyson, Sr Manager Aseptic Operations, Eisai Inc, USA
    16:15 - 17:00 New Step for Sterility Assurance - Sterile Single Use Transfer Applications
    16:15 - 17:00 An introduction to syringe processing: the do's and don'ts
    • Joerg Zimmermann, Dir Process Dev Implementation, Vetter Pharma Fertigung GmbH Co KG, Germany
    17:00 - 18:30 Networking Reception in Exhibit Hall
    Tuesday, 25 February
    07:30 - 08:30 Industry Roundtable: Keys to Addressing Quality System Issues in Aseptic Manufacturing Which May Lead to Shortages
      08:30 - 08:35 Welcome and Introduction
      • Leader: Jack Lysfjord, Principal Consultant, Lysfjord Consulting LLC, USA
      08:30 - 09:15 Innovative Use of Disposables
      • Mayo Pujols, Exec. Dir., Vaccines & Biologics Tech Ops, Merck, USA
      08:35 - 09:20 Case Study: Isolator Technology Based LAV Fill/Finish Facility Design
      09:15 - 10:00 Understanding Isolator Technology: An Engineer’s Guide to Aseptic Processing within a Hydrogen Peroxide Decontaminated Environment
      09:20 - 10:00 Glove Leak Testing in Isolators and RABS-Common Practices, Requirements and Available Methonds
      10:00 - 10:30 Networking Break
      10:30 - 11:15 Upgrading Legacy Systems in Aseptic Area
      • Parag Pande, Sr. Bioprocess Engineering Specialist, Merck Inc., USA
      10:30 - 11:15 Vial Capping Using RABS and Isolators
      11:05 - 12:00 Latest Recommendations for Control of Particles in the Manufacture and Supply of Single Use Systems
      • Eric Isberg, Global Product Manager, Pall Life Sciences, USA
      11:15 - 11:55 Challenges of a Conventional Clean Room Liquid and Lyophilized Vial Filling Line Replacement Utilizing RABS
      • Tony Knox, Mgr Technical Operations, Oso Biopharmaceuticals Mfg LLC, USA
      11:55 - 12:00 Discussion Group Topics and FDA Questions
      • Leader: Ryan Hawkins, VP Ops - Chief Operating Officer, Cook Pharmica, LLC, USA
      • Leader: Ryan Hawkins, VP Ops - Chief Operating Officer, Cook Pharmica, LLC, USA
      • Leader: Ryan Hawkins, VP Ops - Chief Operating Officer, Cook Pharmica, LLC, USA
      11:55 - 12:00 Discussion Group Topics and FDA Questions
      • Klaus Ullherr, Product Manager (PA-PH/BUD13), Robert Bosch GmbH, Germany
      12:00 - 13:00 Lunch
      13:00 - 14:30 Aseptic Processing Technologies and Disposables: Discussion Groups
        13:00 - 14:30 Barrier Isolation & RABS: Discussion Groups
          14:30 - 15:00 Networking Break
          15:00 - 15:30 Aseptic Processing Technologies and Disposables: Discussion Groups Presentations
            15:00 - 15:30 Barrier Isolation & RABS: Discussion Groups Presentations
              15:30 - 17:00 FDA Q&A Panel
              • David Doleski, Director, Office of Manufacturing and Product Quality, FDA/CDER/OC/DGMPA, USA
              • Richard Friedman, Assoc Dir., Off. Mfg & Product Quality, FDA/CDER/OMPQ, USA
              • JR Kelly, Test Account, Test Account, ISPE Test Account, USA
              • Destry Sillivan, Team Leader, FDA/CDER/OCBQ/DMPQ/MRBII, USA

              Announcements:

              Handouts are now available!