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: Jörg Zimmermann, Vice President/Bereichsleiter, Vetter Pharma-Fertigung GmbH & Co., Germany
    11:00 - 11:05  Housekeeping and Intros
    • Leader: Ryan Hawkins, Vice President of Operations, Cook Pharmica, LLC, USA
    11:05 - 11:45  Green Barrier Systems? Energy Consumption Comparison of RABS and Isolator
    • Johannes Rauschnabel, PhD, Chief Pharma Expert - Pkg Tech Div, Robert Bosch GmbH, Germany
      Green Barrier Systems? Energy Consumption Comparision of RABS and Isolator
    11:05 - 11:45  Applying Lean Principles to Parenteral Clinical Supply Manufacture
      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, USA
        Isolation-Based Sterile Facilities: A Conventional Stainless Steel vs. Single-use/Disposable Technology Implementation
      11:45 - 12:30  Patient Centric Supply Chain
      • Carl Hitscherich, PhD, Product Developer, Biogen Idec, USA
        Patient Centric Supply Chain
      12:25 - 12:30  Discussion Group Topics & FDA Questions
      • Leader: Ryan Hawkins, Vice President of Operations, 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, Facilities & Engineering Lead, AstraZeneca, USA
        Challenges in Filling Live Virus Vaccines
      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
      15:00 - 15:30  Networking Break
      15:30 - 16:15  Production Challenges and Benefits of a Fill-Finish Isolator
      15:30 - 16:15  Isolator concept for the filling of cytotoxic drugs
      • Inga Roswadowski, Process Engineer, Syringe Filling, Oncotech Pharma Production GmbH, Germany
        Isolator concept for the filling of cytotoxic drugs
      16:15 - 17:00  An introduction to syringe processing: the do's and don'ts
      • Jörg Zimmermann, Vice President/Bereichsleiter, Vetter Pharma-Fertigung GmbH & Co., Germany
        An Introduction to Syringe Processing: The Do's and Don'ts
      16:15 - 17:00  New Step for Sterility Assurance - Sterile Single Use Transfer Applications
      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, VP Manufacturing, Advaxis Inc, USA
          Innovative Use of Disposables
        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
        • Leslie Edwards, MSE, Director, Eastern Region, SKAN US, Inc., USA
          Glove Leak Testing in Isolators and RABS – A foundation for reasonable testing and good practices for risk mitigation
        10:00 - 10:30  Networking Break
        10:30 - 11:15  Vial Capping Using RABS and Isolators
        10:30 - 11:15  Upgrading Legacy Systems in Aseptic Area
        • Parag Pande, Project Design Manager, Merck & Co Inc., USA
          Upgrading Legacy Systems in Aseptic Area
        11:05 - 12:00  Latest Recommendations for Control of Particles in the Manufacture and Supply of Single Use Systems
        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
          Challenges of a Conventional Clean Room Liquid and Lyophilized Vial Filling Line Replacement Utilizing RABS
        11:55 - 12:00  Discussion Group Topics and FDA Questions
        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  Barrier Isolation & RABS: Discussion Groups
          13:00 - 14:30  Aseptic Processing Technologies and Disposables: 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, Deputy Director (Acting), OPF, FDA/CDER/OPQ/OPF, USA
                • Richard Friedman, Deputy Director, Science and Regulatory Policy, FDA/CDER/OC/OMQ, USA
                • JR Kelly, Test Account, Test Account, ISPE Test Account, USA
                • Destry Sillivan, CDR, USPHS (Ret.), Owner, TCubed Regulatory Consulting, LLC, USA

                Announcements:

                Handouts are now available!